Breast Cancer, Cognitive Dysfunction, Fatigue
Conditions
Keywords
Breast Cancer, Cognition, Fatigue, Cancer-related Cognitive Impairment, Transcranial Direct Current Stimulation
Brief summary
This study will test the preliminary efficacy of transcranial direct current stimulation (tDCS) to improve fatigue and cognition in women with a history of breast cancer and persistent fatigue.
Detailed description
Fatigue and cognitive dysfunction are commonly reported symptoms associated with impaired quality of life and productivity in breast cancer survivors. Transcranial direct current stimulation (tDCS) has been shown to improve both fatigue and cognition. Here tDCS will be used in a randomized, sham-controlled, double-blind, cross-over trial in women who have finished treatment of breast cancer and who report persistent fatigue. Participants will complete measures of fatigue and cognition before and after five consecutive days of active or sham tDCS then complete questionnaires by phone one week later. Participants will return about one month later for another five days of participation, followed by another brief study phone call the following week.
Interventions
DEVICEtDCS
Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
OTHERSham tDCS
Sham Transcranial direct current stimulation (tDCS)..
Sponsors
Under Armour, Inc.
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double-blind
Intervention model description
Randomized, sham-controlled, double-blind, cross-over
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Women, 18 years of age or older * Stage I-III breast cancer * Treatment Status: At least 6 months and no more than 5 years after the conclusion of active breast cancer therapy, including surgery, radiation therapy and (neo)adjuvant chemotherapy, if administered. NOTE: Adjuvant HER2-targeted therapy and endocrine therapy may still be ongoing at the time of study enrollment. * Fatigue: Moderate fatigue on most days within the past week (i.e., at least 4 out of the last 7 days), rated as ≥ 4 on a 0 (no fatigue) to 10 (worst fatigue) scale. * Able and willing to complete study tasks as evidenced by at least the following: fluent English speaker; hearing and language comprehension; and, sufficient literacy to complete study forms and questionnaires. * Patient understands the study regimen, its requirements, risks, and discomforts, and is able and willing to sign an informed consent form.
Exclusion criteria
* Evidence of recurrent breast cancer at the time of enrollment. * Depression or anxiety as defined either by ongoing pharmacological treatment for depression or anxiety or a HADS score on initial screening. * Dementia as assessed by a MMSE score on initial screening. * Known pregnancy or nursing. * Any of the following: diagnosis of schizophrenia or bipolar disorder made by a physician, seizure disorder, pacemaker, hearing aids, any metal implanted in the head, or the presence of other known current untreated causes of fatigue such as anemia or untreated hypothyroidism. * Use of stimulant medications, sleep medications, nicotine patch, and other drugs thought to interfere with tDCS efficacy for seven days prior to and during study participation. * Use of narcotic pain medication, benzodiazepines, or illicit drugs for seven days prior to and during study participation. * Consumption of \>14 alcoholic drinks per week or positive screening on the CAGE. * Skin conditions involving open sores on the scalp that would prevent proper application of the electrodes. * Hairstyles that obstruct placement of the electrodes including cornrows, dreadlocks, braids or other hair accessories that cannot be removed. * Other medical or other condition(s) that in the opinion of the investigators might compromise the objectives of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change on Paced Auditory Serial Attention Test (PASAT) | Baseline and Day 5 | Change in auditory working memory as measured by the PASAT prior to and following the intervention. PASAT scores range from 0 to 120, with higher scores reflecting better working memory. Larger positive change scores reflect greater improvement in performance from baseline whereas greater negative change scores reflect declines in performance from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog) | Baseline and Day 5 | Change in subjective cognitive functioning as measured by the FACT-Cog Perceived Cognitive Impairment scale prior to and following the intervention. Raw scores range from 0 to 72, with higher scores reflecting better perceived cognitive functioning. Larger positive change scores reflect greater improvement in subjective cognitive functioning from baseline whereas greater negative change scores reflect declines in subjective cognitive functioning from baseline. |
| Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF) | Baseline and Day 5 | Change in subjective fatigue as measured by the MFSI-SF prior to and following the intervention. Raw scores range from -36 to + 144, with higher scores reflecting greater levels of fatigue. Larger positive change scores reflect greater improvement in fatigue from baseline whereas greater negative change scores reflect declines in fatigue from baseline. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Active tDCS First 2 mA of active tDCS applied over a 30-minute study session once per day for 5 consecutive days then sham tDCS after washout.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS).. | 3 |
| Sham tDCS First Stimulation mimicking the tDCS applied only briefly over a 30-minute study session once per day for 5 consecutive days then active tDCS after washout.
tDCS: Transcranial direct current stimulation (tDCS) is a safe, portable, non-invasive form TDCS is a form of non-invasive electrical brain stimulation using low amplitude direct current to facilitate neuronal transmission beneath scalp electrodes.
Sham tDCS: Sham Transcranial direct current stimulation (tDCS).. | 4 |
| Total | 7 |
Baseline characteristics
| Characteristic | Sham tDCS First | Total | Active tDCS First |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 4 Participants | 2 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 3 Participants | 1 Participants |
| Age, Continuous | 69 years STANDARD_DEVIATION 11 | 67.0 years STANDARD_DEVIATION 8.22 | 65 years STANDARD_DEVIATION 2.5 |
| 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 | 1 Participants | 1 Participants | 0 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 | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 6 Participants | 3 Participants |
| Region of Enrollment United States | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 7 |
| other Total, other adverse events | 0 / 6 | 0 / 7 |
| serious Total, serious adverse events | 0 / 6 | 0 / 7 |
Outcome results
Primary
Change on Paced Auditory Serial Attention Test (PASAT)
Change in auditory working memory as measured by the PASAT prior to and following the intervention. PASAT scores range from 0 to 120, with higher scores reflecting better working memory. Larger positive change scores reflect greater improvement in performance from baseline whereas greater negative change scores reflect declines in performance from baseline.
Time frame: Baseline and Day 5
Population: Participants who completed both active and sham conditions, allowing for calculation and comparison of change by condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Change on Paced Auditory Serial Attention Test (PASAT) | -1.83 raw score change on a scale | Standard Deviation 5.04 |
| Sham tDCS | Change on Paced Auditory Serial Attention Test (PASAT) | 1.83 raw score change on a scale | Standard Deviation 14.52 |
p-value: 0.47t-test, 2 sided
Secondary
Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF)
Change in subjective fatigue as measured by the MFSI-SF prior to and following the intervention. Raw scores range from -36 to + 144, with higher scores reflecting greater levels of fatigue. Larger positive change scores reflect greater improvement in fatigue from baseline whereas greater negative change scores reflect declines in fatigue from baseline.
Time frame: Baseline and Day 5
Population: Participants who completed both active and sham conditions, allowing for calculation and comparison of change by condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF) | 8.5 raw score change on a scale | Standard Deviation 6.02 |
| Sham tDCS | Change in Multidimensional Fatigue Symptom Inventory- SF (MFSI-SF) | 14.83 raw score change on a scale | Standard Deviation 13.69 |
p-value: 0.36t-test, 2 sided
Secondary
Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog)
Change in subjective cognitive functioning as measured by the FACT-Cog Perceived Cognitive Impairment scale prior to and following the intervention. Raw scores range from 0 to 72, with higher scores reflecting better perceived cognitive functioning. Larger positive change scores reflect greater improvement in subjective cognitive functioning from baseline whereas greater negative change scores reflect declines in subjective cognitive functioning from baseline.
Time frame: Baseline and Day 5
Population: Participants who completed both active and sham conditions, allowing for calculation and comparison of change by condition.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active tDCS | Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog) | 7.17 raw score change on a scale | Standard Deviation 6.55 |
| Sham tDCS | Change on Functional Assessment of Cancer Therapy Cognitive Scale (FACT-Cog) | 8.67 raw score change on a scale | Standard Deviation 12.03 |
p-value: 0.69t-test, 2 sided