Anxiety Disorder, Breast Cancer, Depression, Fatigue, Pain, Sleep Disorders
Conditions
Keywords
depression, anxiety disorder, fatigue, pain, sleep disorders, stage IA breast cancer, stage IB breast cancer, stage II breast cancer, stage IIIA breast cancer
Brief summary
RATIONALE: Cranial microcurrent electrical stimulation (CES) is mild electrical current received through electrodes placed on the earlobes. CES may lessen symptoms in women with breast cancer receiving chemotherapy. It is not yet known whether CES is more effective than sham therapy in reducing symptoms caused by chemotherapy in women with breast cancer. PURPOSE: This randomized phase III trial is studying mild electrical stimulation to see how well it works compared with sham therapy in reducing symptoms caused by chemotherapy in women with stage I, stage II, or stage IIIA breast cancer receiving chemotherapy.
Detailed description
OBJECTIVES: Primary * To compare the effects of cranial microcurrent electrical stimulation (CES) vs sham CES over time on symptoms of depression, anxiety, fatigue, pain, and sleep disturbances in women with stage I-IIIA breast cancer receiving adjuvant chemotherapy. Secondary * To explore the relationships among selected markers of inflammation (e.g., tumor necrosis factor alpha, interleukin-6, interleukin-1β, and C-reactive protein), symptoms, and quality of life. * To examine whether the symptoms of depression, anxiety, fatigue, sleep disturbances, and pain form a cluster. * To examine the effects of CES on quality of life. OUTLINE: Patients are stratified according to chemotherapy schedule (every 2 weeks for 8 courses vs every 3 weeks for 6 courses). Patients are randomized to 1 of 2 treatment arms. * Arm I (cranial microcurrent electrical stimulation \[CES\]): Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18. * Arm II (sham CES): Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18. Patients complete symptom questionnaires (e.g., the Hospital Anxiety and Depression Scale, the Brief Pain Inventory Short-Form, the Brief Fatigue Inventory, and the General Sleep Disturbance Scale) weekly in weeks 1-18. Patients also complete a quality-of-life questionnaire in weeks 1, 7, and 18. Blood samples are collected in weeks 1, 7, and 18 and analyzed for cytokines (e.g., tumor necrosis factor alpha, interleukin-6, and interleukin-1β) and C-reactive protein.
Interventions
PROCEDUREenergy-based therapy
Given once a day for 18 weeks
PROCEDUREsham intervention
Given once a day for 18 weeks
Sponsors
National Cancer Institute (NCI)
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Diagnosis of stage I-IIIA breast cancer * Scheduled to receive adjuvant chemotherapy * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Pre, peri, or post-menopausal * ECOG performance status 0-1 * No dementia * No active psychosis * No history of seizure disorder * No implanted electrical device PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior chemotherapy * No initiation of a medication regimen for depression or other psychiatric condition within the past 30 days
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer | Up to 2 weeks afer completion of study treatment, for up to 8 months | Using Hospital Anxiety and Depression Scale (HADS) a 14 item scale, 7 relate to anxiety, 7 to depression; each item is scored from 0-3, a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. Has 9 questions with 0 (does not interfere) to 10 (completely interferes), the total mean score is the mean of the 9 questions; severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Baseline | Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. |
| Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Baseline | Simple correlations will be computed at Baseline for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. |
| Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline | Baseline | Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system. |
| Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Baseline | Simple correlations will be computed at Baseline Chemotherapy for symptoms. |
| Relationships Among Quality of Life Scores - Means at Baseline | Baseline | Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life. |
| Relationships Among Quality of Life Scores - Correlations at Baseline | Baseline | Simple correlations will be computed at Baseline for quality of life scores. |
| Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Midpoint Chemotherapy, up to 4 months | Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. |
| Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy | Midpoint Chemotherapy, up to 4 months | Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. |
| To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | up to 2 weeks after completion of study treatment, for up to 8 months | Examine correlations between the symptoms at baseline to determine a general pattern of association. Factor analysis (a statistical method used to describe variability among observed, correlated variables in terms of a potentially lower number of unobserved variables called factors) was performed to examine how these 5 symptoms cluster. A principal component factor analysis was performed on the correlation matrix for the symptom scores of anxiety, depression, pain, fatigue and sleep disturbance at up to two weeks after completion of study treatment, up to 8 months). For each analysis two factors were retained that explained 74% of the variability for the baseline symptom scores, 79% of the variability of the symptom scores at the midpoint and 78% of the variability in symptom scores at study completion. A varimax rotation was utilized and the factor loadings from the varimax rotation were reported. |
| Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Midpoint Chemotherapy, up to 4 months | Simple correlations will be computed at Midpoint Chemotherapy for symptoms. |
| Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy | Midpoint Chemotherapy, up to 4 months | Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life. |
| Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy | Midpoint Chemotherapy, up to 4 months | Simple correlations will be computed at Midpoint Chemotherapy for quality of life scores. |
| Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment | Up to 2 weeks afer completion of study treatment, for up to 8 months | Simple correlations will be computed at Chemotherapy End of Treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation. |
| Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy | Up to 2 weeks afer completion of study treatment, for up to 8 months | Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system. |
| Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Up to 2 weeks afer completion of study treatment, for up to 8 months | Simple correlations will be computed at end of Chemotherapy for symptoms. |
| Effects of Treatment on Quality of Life - Means at End of Treatment | up to 2 weeks after completion of study treatment, for up to 8 months | Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not al all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life. |
| Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy | Up to 2 weeks afer completion of study treatment, for up to 8 months | Simple correlations will be computed at End of Chemotherapy for quality of life scores. |
| Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy | Midpoint Chemotherapy, up to 4 months | Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system. |
Participant flow
Recruitment details
Women with stage I to IIIA breast cancer scheduled to receive chemotherapy with a performance score \<2 recruited from five Cancer Centers across Virginia. Previous chemotherapy, dementia or active psychosis, seizure disorder, implanted electrical device, or taking medication psychiatric condition with 30 days prior to enrollment were excluded.
Pre-assignment details
Following completion of informed consent study participants were stratified by initial chemotherapy regimen (dose dense versus non-dose dense) and then randomly assigned to one of two groups: actual or sham CES.
Participants by arm
| Arm | Count |
|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) Patients receive a CES unit (Alpha-Stim® 100 Microcurrent Stimulator) that passes microcurrent levels of biphasic electrical stimulation via ear-lobe electrodes. The CES unit is preset to provide 1 hour of 100 μA (sub-sensory level), modified square-wave biphasic stimulation on a 50% duty cycle at .05 Hz, and to automatically turn off at the end of 1 hour. Patients use their CES unit once daily in weeks 1-18.
energy-based therapy: Given once a day for 18 weeks | 77 |
| Arm II (Sham CES) Patients receive a CES unit as in arm I, but the ear-lobe electrodes do not pass electrical current. Patients use their CES unit once daily in weeks 1-18.
sham intervention: Given once a day for 18 weeks | 75 |
| Total | 152 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | No post baseline data | 1 | 0 |
| Overall Study | Too overwhelmed by treatment | 2 | 5 |
Baseline characteristics
| Characteristic | Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Total | Arm II (Sham CES) |
|---|---|---|---|
| Age, Continuous | 51.03 years STANDARD_DEVIATION 11.06 | 51.22 years STANDARD_DEVIATION 9.805 | 51.41 years STANDARD_DEVIATION 8.55 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 28 Participants | 50 Participants | 22 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 4 Participants |
| Race (NIH/OMB) White | 46 Participants | 95 Participants | 49 Participants |
| Region of Enrollment United States | 77 participants | 152 participants | 75 participants |
| Sex: Female, Male Female | 77 Participants | 152 Participants | 75 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Stage of Disease Phase I | 16 participants | 34 participants | 18 participants |
| Stage of Disease Phase II | 51 participants | 94 participants | 43 participants |
| Stage of Disease Phase III | 10 participants | 24 participants | 14 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 77 | 0 / 75 |
| serious Total, serious adverse events | 1 / 77 | 0 / 75 |
Outcome results
Primary
Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer
Using Hospital Anxiety and Depression Scale (HADS) a 14 item scale, 7 relate to anxiety, 7 to depression; each item is scored from 0-3, a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. Has 9 questions with 0 (does not interfere) to 10 (completely interferes), the total mean score is the mean of the 9 questions; severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire
Time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer | Depression | 4.520 units on a scale | Standard Deviation 0.398 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer | Pain | 1.174 units on a scale | Standard Deviation 0.197 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer | Fatigue | 3.349 units on a scale | Standard Deviation 0.294 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer | Sleep | 38.235 units on a scale | Standard Deviation 2.376 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer | Anxiety | 4.040 units on a scale | Standard Deviation 0.419 |
| Arm II (Sham CES) | Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer | Sleep | 40.474 units on a scale | Standard Deviation 2.443 |
| Arm II (Sham CES) | Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer | Anxiety | 4.529 units on a scale | Standard Deviation 0.431 |
| Arm II (Sham CES) | Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer | Depression | 4.565 units on a scale | Standard Deviation 0.407 |
| Arm II (Sham CES) | Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer | Fatigue | 3.191 units on a scale | Standard Deviation 0.301 |
| Arm II (Sham CES) | Effects of CES as Compared to Sham CES on Symptoms of Depression, Anxiety, Fatigue, Pain and Sleep Disturbances in Women Receiving Adjuvant Chemotherapy for Early-stage Breast Cancer | Pain | 1.272 units on a scale | Standard Deviation 0.202 |
Secondary
Effects of Treatment on Quality of Life - Means at End of Treatment
Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not al all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.
Time frame: up to 2 weeks after completion of study treatment, for up to 8 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Effects of Treatment on Quality of Life - Means at End of Treatment | Total Score | 108.11 units on a scale | Standard Error 2.52 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Effects of Treatment on Quality of Life - Means at End of Treatment | Breast Cancer Specific | 25.51 units on a scale | Standard Error 0.75 |
| Arm II (Sham CES) | Effects of Treatment on Quality of Life - Means at End of Treatment | Total Score | 105.96 units on a scale | Standard Error 2.59 |
| Arm II (Sham CES) | Effects of Treatment on Quality of Life - Means at End of Treatment | Breast Cancer Specific | 24.66 units on a scale | Standard Error 0.77 |
Secondary
Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time frame: Midpoint Chemotherapy, up to 4 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (CRP) | 28.62 Log (pg/ml) | Standard Deviation 1.69 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (IL-1B) | 6.52 Log (pg/ml) | Standard Deviation 52.59 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (IL6) | -0.22 Log (pg/ml) | Standard Deviation 2.91 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (TNF-a) | -0.89 Log (pg/ml) | Standard Deviation 3.52 |
| Arm II (Sham CES) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (TNF-a) | -0.15 Log (pg/ml) | Standard Deviation 3.68 |
| Arm II (Sham CES) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (CRP) | 29.09 Log (pg/ml) | Standard Deviation 1.18 |
| Arm II (Sham CES) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (IL6) | 0.55 Log (pg/ml) | Standard Deviation 2.8 |
| Arm II (Sham CES) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (IL-1B) | 24.68 Log (pg/ml) | Standard Deviation 171.81 |
Secondary
Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Simple correlations will be computed after completion of study treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time frame: Up to 2 weeks after completion of study treatment, for up to 8 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (CRP) | 28.64 Log (pg/ml) | Standard Deviation 1.26 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (IL-1B) | 10.50 Log (pg/ml) | Standard Deviation 83.81 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (IL6) | 0.68 Log (pg/ml) | Standard Deviation 2.29 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (TNF-a) | -1.34 Log (pg/ml) | Standard Deviation 3.64 |
| Arm II (Sham CES) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (TNF-a) | -0.33 Log (pg/ml) | Standard Deviation 3.22 |
| Arm II (Sham CES) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (CRP) | 29.00 Log (pg/ml) | Standard Deviation 1.32 |
| Arm II (Sham CES) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (IL6) | 0.73 Log (pg/ml) | Standard Deviation 2.26 |
| Arm II (Sham CES) | Mean and Standard Deviation of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log (IL-1B) | 1.35 Log (pg/ml) | Standard Deviation 5.65 |
Secondary
Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time frame: Baseline
Population: Per protocol, for all subjects with available data. No imputation was utilized.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log(CRP pg/ml) | 28.64 Log(pg/ml) | Standard Deviation 1.67 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log(IL-1b pg/ml) | 9.88 Log(pg/ml) | Standard Deviation 69.85 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log(IL-6 pg/ml) | 0.33 Log(pg/ml) | Standard Deviation 2.65 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log(TNF-a pg/ml) | -0.63 Log(pg/ml) | Standard Deviation 3.49 |
| Arm II (Sham CES) | Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log(TNF-a pg/ml) | -0.19 Log(pg/ml) | Standard Deviation 3.49 |
| Arm II (Sham CES) | Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log(CRP pg/ml) | 28.92 Log(pg/ml) | Standard Deviation 1.32 |
| Arm II (Sham CES) | Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log(IL-6 pg/ml) | 0.09 Log(pg/ml) | Standard Deviation 3.21 |
| Arm II (Sham CES) | Means and Standard Deviations of Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Log(IL-1b pg/ml) | 32.60 Log(pg/ml) | Standard Deviation 259.03 |
Comparison: Spearman correlation coefficients were computed for the biomarkers. P-Values shown are not adjusted for multiple comparisons. The a priori threshold for statistical significance was P less than 0.05. This information applies to all rows listed in the table.p-value: <0.05t-test, 2 sided
Secondary
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline
Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline | Depression | 3.03 units on a scale | Standard Deviation 2.48 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline | Pain | 1.24 units on a scale | Standard Deviation 2.05 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline | Fatigue | 1.95 units on a scale | Standard Deviation 2.71 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline | Sleep | 40.70 units on a scale | Standard Deviation 24.83 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline | Anxiety | 7.09 units on a scale | Standard Deviation 4.09 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline | Sleep | 40.30 units on a scale | Standard Deviation 23.87 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline | Anxiety | 7.59 units on a scale | Standard Deviation 4.13 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline | Depression | 3.06 units on a scale | Standard Deviation 2.78 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline | Fatigue | 2.63 units on a scale | Standard Deviation 2.89 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Baseline | Pain | 1.45 units on a scale | Standard Deviation 1.98 |
Secondary
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy
Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.
Time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy | Depression | 4.47 units on a scale | Standard Deviation 3.36 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy | Pain | 1.14 units on a scale | Standard Deviation 1.65 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy | Fatigue | 3.34 units on a scale | Standard Deviation 2.47 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy | Sleep | 38.50 units on a scale | Standard Deviation 20.19 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy | Anxiety | 4.07 units on a scale | Standard Deviation 3.51 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy | Sleep | 40.91 units on a scale | Standard Deviation 21.21 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy | Anxiety | 4.51 units on a scale | Standard Deviation 4.04 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy | Depression | 4.63 units on a scale | Standard Deviation 3.67 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy | Fatigue | 3.32 units on a scale | Standard Deviation 2.55 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at End of Chemotherapy | Pain | 1.32 units on a scale | Standard Deviation 1.8 |
Secondary
Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy
Measured using Hospital Anxiety and Depression Scale (HADS) a fourteen item scale, 7 relate to anxiety and 7 to depression; each item is scored from 0-3, this means a person can score 0 to 21 for either anxiety or depression (0 is best and 21 is worst), Brief Pain Inventory (BPI) short-form measures the intensity of pain and interference of pain in the patient's life; 12 questions with 0 (does not interfere) to 10 (completely interferes); mean will be used as the measure of pain; Brief Fatigue Inventory (BFI) assess the severity and impact of cancer-related fatigue. it has 9 questions with 0 (does not interfere) to 10 (completely interferes); severe fatigue can be defined as a score of 7 or higher, General Sleep Disturbance Scale (GSDS) 21 items to evaluate sleep issues (0=never to 7=every day); the 21 items are summed to produce a total score of 9=no sleep disturbance to 137=extreme sleep disturbance . Used standard questionnaire scoring system.
Time frame: Midpoint Chemotherapy, up to 4 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy | Depression | 4.24 units on a scale | Standard Deviation 3.22 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy | Pain | 1.25 units on a scale | Standard Deviation 1.44 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy | Fatigue | 3.15 units on a scale | Standard Deviation 2.21 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy | Sleep | 38.70 units on a scale | Standard Deviation 18.28 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy | Anxiety | 4.40 units on a scale | Standard Deviation 3.19 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy | Sleep | 42.44 units on a scale | Standard Deviation 21.73 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy | Anxiety | 4.98 units on a scale | Standard Deviation 3.72 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy | Depression | 4.02 units on a scale | Standard Deviation 3.14 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy | Fatigue | 3.14 units on a scale | Standard Deviation 2.39 |
| Arm II (Sham CES) | Relationships Among Anxiety, Depression, Fatigue, Pain and Sleep Scores - Means at Midpoint Chemotherapy | Pain | 1.09 units on a scale | Standard Deviation 1.56 |
Secondary
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment
Simple correlations will be computed at Chemotherapy End of Treatment for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment | Correlation between Log (CRP)-Log (IL-1B) | 0.057 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment | Correlation between Log (CRP)-Log IL6) | 0.343 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment | Correlation between Log (CRP)-Log (TNF-a) | 0.135 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment | Correlation between Log (IL-1B)-Log (IL6) | 0.383 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment | Correlation between Log (IL-1B)-Log (TNF-a) | 0.464 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at End of Treatment | Correlation between Log (IL6)-Log (TNF-a) | 0.134 correlation coefficient |
Secondary
Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy
Simple correlations will be computed at Midpoint Chemotherapy for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time frame: Midpoint Chemotherapy, up to 4 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy | Correlation between Log (CRP)-Log IL6) | 0.337 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy | Correlation between Log (CRP)-Log (TNF-a) | 0.102 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy | Correlation between Log (CRP)-Log (IL-1B) | 0.060 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy | Correlation between Log (IL-1B)-Log (IL6) | 0.390 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy | Correlation between Log (IL-1B)-Log (TNF-a) | 0.593 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log (CRP), Log (IL-1B), Log (IL6), and Log (TNF-a) - Correlations at Midpoint Chemotherapy | Correlation between Log (IL6)-Log (TNF-a) | 0.298 correlation coefficient |
Secondary
Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml).
Simple correlations will be computed at Baseline for the log transformed biomarker values; IL1-β, IL-6, TNF-α, CRP. These are the biomarkers of inflammation.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Correlation between Log (IL6)-Log (TNF-a) | 0.320 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Correlation between Log (CRP)-Log (IL-1B) | 0.031 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Correlation between Log (CRP)-Log IL6) | 0.243 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Correlation between Log (CRP)-Log (TNF-a) | 0.002 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Correlation between Log (IL-1B)-Log (IL6) | 0.453 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Biomarkers Log(CRP pg/ml), Log(IL-1b pg/ml), Log(IL-6 pg/ml) and Log(TNF-a pg/ml). | Correlation between Log (IL-1B)-Log (TNF-a) | 0.570 correlation coefficient |
Secondary
Relationships Among Quality of Life Scores - Correlations at Baseline
Simple correlations will be computed at Baseline for quality of life scores.
Time frame: Baseline
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Quality of Life Scores - Correlations at Baseline | 0.744 correlation coefficient |
Secondary
Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy
Simple correlations will be computed at End of Chemotherapy for quality of life scores.
Time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Quality of Life Scores - Correlations at End of Chemotherapy | 0.772 correlation coefficient |
Secondary
Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy
Simple correlations will be computed at Midpoint Chemotherapy for quality of life scores.
Time frame: Midpoint Chemotherapy, up to 4 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Quality of Life Scores - Correlations at Midpoint Chemotherapy | 0.743 correlation coefficient |
Secondary
Relationships Among Quality of Life Scores - Means at Baseline
Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.
Time frame: Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Quality of Life Scores - Means at Baseline | FACT-B Total | 113.44 units on a scale | Standard Deviation 17.65 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Quality of Life Scores - Means at Baseline | FACT-B BCA Specific | 27.42 units on a scale | Standard Deviation 5.05 |
| Arm II (Sham CES) | Relationships Among Quality of Life Scores - Means at Baseline | FACT-B Total | 111.83 units on a scale | Standard Deviation 17.91 |
| Arm II (Sham CES) | Relationships Among Quality of Life Scores - Means at Baseline | FACT-B BCA Specific | 26.05 units on a scale | Standard Deviation 6.04 |
Secondary
Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy
Measured using the Functional Assessment of Cancer Therapy for Patients with Breast Cancer (FACT-B). A 44-item self-report instrument designed to measure multidimensional quality of life in patient with breast cancer. 0=not at all to 4=very much. Utilized standard questionnaire scoring system. The items are summed to produce a total score 0=not at all to 176=very much. The FACT-B BCA has 10 questions that range from 0 (not at all) to 4 (very much); thus the FACT-B BCA ranges from 0 to 40. Both the FACT-B and FACT-BCA are scored so that high scores indicate higher levels of quality of life.
Time frame: Midpoint Chemotherapy, up to 4 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy | FACT-B Total | 111.57 units on a scale | Standard Deviation 18.35 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy | FACT-B BCA Specific | 26.96 units on a scale | Standard Deviation 5.47 |
| Arm II (Sham CES) | Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy | FACT-B Total | 108.45 units on a scale | Standard Deviation 22.46 |
| Arm II (Sham CES) | Relationships Among Quality of Life Scores - Means at Midpoint Chemotherapy | FACT-B BCA Specific | 25.96 units on a scale | Standard Deviation 5.39 |
Secondary
Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy
Simple correlations will be computed at Baseline Chemotherapy for symptoms.
Time frame: Baseline
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Correlation between Anxiety-Depression | 0.610 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Correlation between Anxiety-Fatigue | 0.303 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Correlation between Anxiety-Pain | 0.298 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Correlation between Anxiety-Sleep | 0.474 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Correlation between Depression-Fatigue | 0.343 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Correlation between Depression-Pain | 0.315 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Correlation between Depression-Sleep | 0.488 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Correlation between Fatigue-Pain | 0.482 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Correlation between Fatigue-Sleep | 0.492 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Baseline Chemotherapy | Correlation between Pain-Sleep | 0.388 correlation coefficient |
Secondary
Relationships Among Symptom Scores - Correlations at End of Chemotherapy
Simple correlations will be computed at end of Chemotherapy for symptoms.
Time frame: Up to 2 weeks afer completion of study treatment, for up to 8 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Correlation between Anxiety-Fatigue | 0.467 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Correlation between Anxiety-Depression | 0.678 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Correlation between Anxiety-Pain | 0.409 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Correlation between Anxiety-Sleep | 0.515 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Correlation between Depression-Fatigue | 0.564 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Correlation between Depression-Pain | 0.368 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Correlation between Depression-Sleep | 0.637 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Correlation between Fatigue-Pain | 0.488 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Correlation between Fatigue-Sleep | 0.643 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at End of Chemotherapy | Correlation between Pain-Sleep | 0.484 correlation coefficient |
Secondary
Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy
Simple correlations will be computed at Midpoint Chemotherapy for symptoms.
Time frame: Midpoint Chemotherapy, up to 4 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Correlation between Anxiety-Depression | 0.723 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Correlation between Anxiety-Fatigue | 0.512 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Correlation between Anxiety-Pain | 0.305 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Correlation between Anxiety-Sleep | 0.604 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Correlation between Depression-Fatigue | 0.632 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Correlation between Depression-Pain | 0.412 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Correlation between Depression-Sleep | 0.624 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Correlation between Fatigue-Pain | 0.507 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Correlation between Fatigue-Sleep | 0.719 correlation coefficient |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | Relationships Among Symptom Scores - Correlations at Midpoint Chemotherapy | Correlation between Pain-Sleep | 0.429 correlation coefficient |
Secondary
To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster.
Examine correlations between the symptoms at baseline to determine a general pattern of association. Factor analysis (a statistical method used to describe variability among observed, correlated variables in terms of a potentially lower number of unobserved variables called factors) was performed to examine how these 5 symptoms cluster. A principal component factor analysis was performed on the correlation matrix for the symptom scores of anxiety, depression, pain, fatigue and sleep disturbance at up to two weeks after completion of study treatment, up to 8 months). For each analysis two factors were retained that explained 74% of the variability for the baseline symptom scores, 79% of the variability of the symptom scores at the midpoint and 78% of the variability in symptom scores at study completion. A varimax rotation was utilized and the factor loadings from the varimax rotation were reported.
Time frame: up to 2 weeks after completion of study treatment, for up to 8 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Anxiety Factor 1 Loading-Baseline | 20 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Anxeity Factor 2 Loading-Baseline | 85 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Anxiety Factor 1 Loading-Midpoint Chemotherapy | 89 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Anxiety Factor 2 Loading-Midpoint Chemotherapy | 9 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Anxiety Factor 1 Loading-Post Chemotherapy | 88 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Anxiety Factor 2 Loading-Post Chemotherapy | 22 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Depression Factor 1 Loading-Baseline | 16 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Depression Factor 2 Loading-Baseline | 87 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Depression Factor 1 Loading-Midpoint Chemotherapy | 76 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Depression Factor 2 Loading-Midpoint Chemotherapy | 43 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Depression Factor 1 Loading-Post Chemotherapy | 86 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Depression Factor 2 Loading-Post Chemotherapy | 31 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Fatigue Factor 1 Loading-Baseline | 85 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Fatigue Factor 2 Loading-Baseline | 16 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Fatigue Factor 1 Loading-Midpoint Chemotherapy | 63 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Fatigue Factor 2 Loading-Midpoint Chemotherapy | 59 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Fatigue Factor 1 Loading-Post Chemotherapy | 44 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Fatigue Factor 2 Loading-Post Chemotherapy | 73 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Pain Factor 1 Loading-Baseline | 83 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Pain Factor 2 Loading-Baseline | 12 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Pain Factor 1 Loading-Midpoint Chemotherapy | 18 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Pain Factor 2 Loading-Midpoint Chemotherapy | 94 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Pain Factor 1 Loading-Post Chemotherapy | 13 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Pain Factor 2 Loading-Post Chemotherapy | 89 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Sleep Factor 1 Loading-Baseline | 67 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Sleep Factor 2 Loading-Baseline | 48 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Sleep Factor 1 Loading-Midpoint Chemotherapy | 79 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Sleep Factor 2 Loading-Midpoint Chemotherapy | 31 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Sleep Factor 1 Loading-Post Chemotherapy | 52 Rotated factor loading multiplied by 100 |
| Arm I (Cranial Microcurrent Electrical Stimulation [CES]) | To Examine Whether the Symptoms of Depression, Anxiety, Fatigue, Sleep Disturbances and Pain Form a Cluster. | Sleep Factor 2 Loading-Post Chemotherapy | 67 Rotated factor loading multiplied by 100 |