Anatomic Stage IA Breast Cancer AJCC v8, Anatomic Stage IB Breast Cancer AJCC v8, Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage IIA Breast Cancer AJCC v8, Anatomic Stage IIB Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8, Anatomic Stage IIIB Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Anatomic Stage IIIC Breast Cancer AJCC v8, Grade 1 Peripheral Motor Neuropathy, CTCAE, Grade 1 Peripheral Sensory Neuropathy, CTCAE, Grade 2 Peripheral Motor Neuropathy, CTCAE, Grade 2 Peripheral Sensory Neuropathy, CTCAE, Prognostic Stage IA Breast Cancer AJCC v8, Prognostic Stage IB Breast Cancer AJCC v8, Prognostic Stage I Breast Cancer AJCC v8, Prognostic Stage IIA Breast Cancer AJCC v8, Prognostic Stage IIB Breast Cancer AJCC v8, Prognostic Stage II Breast Cancer AJCC v8, Prognostic Stage IIIA Breast Cancer AJCC v8, Prognostic Stage IIIB Breast Cancer AJCC v8, Prognostic Stage III Breast Cancer AJCC v8, Prognostic Stage IIIC Breast Cancer AJCC v8
Conditions
Brief summary
The goal of this study is to obtain preliminary evidence of the effect of 8 acupuncture treatments over 10 weeks in breast and GI cancer patients who are currently receiving or recently completed active neurotoxic chemotherapy and have clinically documented grade 1 or 2 neuropathy.
Detailed description
PRIMARY OBJECTIVES: I. To obtain preliminary evidence of the clinical effects of acupuncture compared to usual care on the change in sensory neuropathic pain as measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 item (20) sensory subscale. SECONDARY OBJECTIVES: I. Change in the motor and autonomic neuropathic pain subscores on the EORTC QLQ-CIPN20. II. Change in patient-reported assessment of numbness and tingling using the 2-item Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) measure. III. Preventing the escalation of CIPN from grade 1 or 2 to a higher grade. IV. Amount and intensity of planned chemotherapy relative to completed chemotherapy. V. Effect on sensory and motor nerve function via nerve conduction studies (NCS) (e.g. conduction velocity, latency, and amplitude). VI. Effect on peripheral nerve swelling via nerve ultrasound (e.g. cross sectional area, CSA). EXPLORATORY OBJECTIVES: I. To obtain preliminary evidence on phenotypic differences between African-American and non African-American (A-A) (i.e., white, Asian, etc.) with regard to presentation of CIPN as well as response to the intervention. II. To obtain preliminary evidence of the effect of acupuncture on intraepidermal nerve fiber density (IENF) via skin biopsy. III. To examine the associations among the peripheral nerve assessment measures (nerve conduction, peripheral nerve ultrasound, skin biopsy) and of the peripheral nerve assessment measures with the patient reported outcomes (EORTC QLQ-CIN20, PRO-CTCAE) at baseline, week 12, and for the change from baseline to week 12. IV. To examine the association between expectations of the effectiveness of acupuncture to reduce peripheral neuropathy and baseline, 12 week, and change in patient-reported outcomes on the EORTC QLQ-CIPN20 and PRO-CTCAE. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP 1: Participants undergo 8 45-minute acupuncture treatments over 10 weeks. GROUP 2: Participants receive usual care. After completion of study treatment, participants are followed up at 12 weeks.
Interventions
PROCEDUREAcupuncture Therapy
Undergo acupuncture therapy
OTHERBest Practice
Receive usual care
OTHERQuality-of-Life Assessment
Ancillary studies
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Wake Forest University Health Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Breast and GI cancer stage I-III * Currently receiving or recently completed neurotoxic chemotherapy (either adjuvant or neoadjuvant). Currently is defined as including up until when the next cycle would be delivered, that is if the patient is getting chemotherapy every week, this would include a week after their last treatment; if the patient is getting treatment every 2 weeks, this would include 2 weeks after their last treatment; if the patient is getting treatment every 3 weeks, this would include 3 weeks after their last treatment, etc. Recently completed is defined as 6 weeks after this time period. For example, if a patient was getting chemotherapy every week, this would include seven weeks after their last treatment; if the patient was getting treatment every 2 weeks, this would include 8 weeks after their last treatment; if the patient were getting treatment every 3 weeks, this would include 9 weeks after their last treatment, etc. * Clinical symptoms of peripheral neuropathy of grade 1 or grade 2 as measured by the National Cancer Institute (NCI)-CTCAE * Ability and willingness to understand and sign an informed consent
Exclusion criteria
* Self-reported or documented history of UNRESOLVED pre-existing peripheral neuropathy due to diabetes, human immunodeficiency virus (HIV), or other conditions. * Unable to provide medical history. * Male patients. * Pregnant. * Unwilling to receive acupuncture or unable to travel for treatments.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20) | Baseline up to week 12 | Will estimate means and standard deviations by group for the EORTC QLQ-CIPN20 sensory subscale, the correlation between the two measures, and the within-person change. To estimate effect size, we will use an analysis of covariance (ANCOVA) model at week 12, which will include the group and the baseline value. Using a 4-point Likert scale (1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded) \[13\]. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Baseline up to week 12 | Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Using a 4-point Likert scale (1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden. |
| Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline up to week 12 | Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period. |
| CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Up to week 12 | The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period. |
| Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy | Up to week 12 | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points |
| Number of Cycles of Completed Chemotherapy | Up to week 12 | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. |
| Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Up to week 12 | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. |
| Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Up to week 12 | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Nerve conduction studies measure impairment of electrical function in large peripheral nerves and measures amplitude and latency of neuronal signaling. Ranging from 0.1 μm to 20 μm. Reduction in the amplitude indicates axonal damage. |
| Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Up to week 12 | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. |
| Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Up to week 12 | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. |
| Nerve Fiber Density in the Skin | Up to week 12 | Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 (Acupuncture) Participants undergo 8 45-minute acupuncture treatments over 10 weeks.
Acupuncture Therapy: Undergo acupuncture therapy
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 11 |
| Group 2 (Usual Care) Participants receive usual care.
Best Practice: Receive usual care
Quality-of-Life Assessment: Ancillary studies
Questionnaire Administration: Ancillary studies | 12 |
| Total | 23 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 1 |
Baseline characteristics
| Characteristic | Group 1 (Acupuncture) | Total | Group 2 (Usual Care) |
|---|---|---|---|
| Age, Continuous | 51.0 years STANDARD_DEVIATION 10.6 | 56.5 years STANDARD_DEVIATION 11.7 | 56.8 years STANDARD_DEVIATION 12.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 11 Participants | 23 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| 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 | 3 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 9 Participants | 17 Participants | 8 Participants |
| Region of Enrollment United States | 11 participants | 23 participants | 12 participants |
| Sex: Female, Male Female | 11 Participants | 23 Participants | 12 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 / 11 | 1 / 12 |
| other Total, other adverse events | 0 / 11 | 1 / 12 |
| serious Total, serious adverse events | 0 / 11 | 0 / 12 |
Outcome results
Primary
Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20)
Will estimate means and standard deviations by group for the EORTC QLQ-CIPN20 sensory subscale, the correlation between the two measures, and the within-person change. To estimate effect size, we will use an analysis of covariance (ANCOVA) model at week 12, which will include the group and the baseline value. Using a 4-point Likert scale (1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded) \[13\]. All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.
Time frame: Baseline up to week 12
Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Acupuncture) | Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20) | Baseline | 16.7 score on a scale | Standard Deviation 3.7 |
| Group 1 (Acupuncture) | Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20) | Week 12 | 13.7 score on a scale | Standard Deviation 2.7 |
| Group 1 (Acupuncture) | Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20) | Week 12 - Baseline (Change) | -2.9 score on a scale | Standard Deviation 4.2 |
| Group 2 (Usual Care) | Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20) | Baseline | 17.5 score on a scale | Standard Deviation 3 |
| Group 2 (Usual Care) | Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20) | Week 12 | 14.8 score on a scale | Standard Deviation 5.2 |
| Group 2 (Usual Care) | Change in the Sensory Neuropathic Pain Score as Measured by the European Organization of Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-Chemotherapy-Induced Peripheral Neuropathy (CIPN) 20 Item (20) | Week 12 - Baseline (Change) | -2.5 score on a scale | Standard Deviation 5.8 |
p-value: 0.61ANCOVA
Secondary
Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Nerve conduction studies measure impairment of electrical function in large peripheral nerves and measures amplitude and latency of neuronal signaling. Ranging from 0.1 μm to 20 μm. Reduction in the amplitude indicates axonal damage.
Time frame: Up to week 12
Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Amplitude - Tibial, ankle | 12.4 micrometers | Standard Deviation 5.2 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Baseline - Amplitude - Tibial, pop fossa (Change) | 1.0 micrometers | Standard Deviation 3.4 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Amplitude (sural) | 8.8 micrometers | Standard Deviation 3.6 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Baseline - Amplitude - median, wrist | 9.6 micrometers | Standard Deviation 3.6 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Baseline - Amplitude - Tibial, ankle (Change) | -1.5 micrometers | Standard Deviation 1.9 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Amplitude - median, wrist | 10.1 micrometers | Standard Deviation 4.4 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Baseline - Amplitude - Tibial, ankle | 13.3 micrometers | Standard Deviation 5.6 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Baseline - Amplitude - median, wrist (Change) | 0.1 micrometers | Standard Deviation 3.3 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Baseline - Amplitude - Tibial, pop fossa | 8.5 micrometers | Standard Deviation 5.2 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Baseline - Amplitude - median, elbow | 9.3 micrometers | Standard Deviation 3.7 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Baseline Amplitude (sural) | -1.5 micrometers | Standard Deviation 4.6 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Amplitude - median, elbow | 9.3 micrometers | Standard Deviation 4 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Amplitude - Tibial, pop fossa | 10.0 micrometers | Standard Deviation 4.4 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Baseline Amplitude - median, elbow (Change) | -0.3 micrometers | Standard Deviation 3.1 |
| Group 1 (Acupuncture) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Baseline - Amplitude (sural) | 9.5 micrometers | Standard Deviation 5 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Baseline Amplitude - median, elbow (Change) | 0.5 micrometers | Standard Deviation 2.3 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Baseline - Amplitude (sural) | 9.5 micrometers | Standard Deviation 7.6 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Amplitude (sural) | 10.9 micrometers | Standard Deviation 7.8 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Baseline Amplitude (sural) | 0.7 micrometers | Standard Deviation 1.8 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Baseline - Amplitude - Tibial, ankle | 11.0 micrometers | Standard Deviation 3.8 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Amplitude - Tibial, ankle | 11.5 micrometers | Standard Deviation 3.5 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Baseline - Amplitude - Tibial, ankle (Change) | -0.2 micrometers | Standard Deviation 1.7 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Baseline - Amplitude - Tibial, pop fossa | 7.8 micrometers | Standard Deviation 3.7 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Amplitude - Tibial, pop fossa | 7.9 micrometers | Standard Deviation 3 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Baseline - Amplitude - Tibial, pop fossa (Change) | -0.8 micrometers | Standard Deviation 1.9 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Baseline - Amplitude - median, wrist | 10.3 micrometers | Standard Deviation 2.8 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Amplitude - median, wrist | 11.2 micrometers | Standard Deviation 2.7 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Baseline - Amplitude - median, wrist (Change) | 0.4 micrometers | Standard Deviation 2.4 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Baseline - Amplitude - median, elbow | 10.0 micrometers | Standard Deviation 2.8 |
| Group 2 (Usual Care) | Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median) | Week 12 - Amplitude - median, elbow | 10.8 micrometers | Standard Deviation 2.7 |
p-value: 0.2ANCOVA
p-value: 0.28ANCOVA
p-value: 0.13ANCOVA
p-value: 0.71ANCOVA
p-value: 0.46ANCOVA
Secondary
Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20
Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. Using a 4-point Likert scale (1 = not at all, 2 = a little, 3 = quite a bit, and 4 = very much), individuals indicate the degree to which they have experienced sensory, motor, and autonomic symptoms during the past week. Sensory raw scale scores range from 1 to 36, motor raw scale scores range from 1 to 32, and autonomic raw scale scores range from 1 to 12 for men and 1-8 for women (erectile function item is excluded). All scale scores are linearly converted to a 0-100 scale, with higher scores indicating more symptom burden.
Time frame: Baseline up to week 12
Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Acupuncture) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Baseline EORTC Subscale | 11.1 score on a scale | Standard Deviation 3.2 |
| Group 1 (Acupuncture) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Week 12 EORTC Subscale | 11.0 score on a scale | Standard Deviation 1.8 |
| Group 1 (Acupuncture) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Week 12 - Baseline (Change) EORTC Subscale | 0.1 score on a scale | Standard Deviation 2.2 |
| Group 1 (Acupuncture) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Baseline EORTC Autonomic Subscale | 2.7 score on a scale | Standard Deviation 0.9 |
| Group 1 (Acupuncture) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Week 12 - EORTC Autonomic Subscale | 2.4 score on a scale | Standard Deviation 0.7 |
| Group 1 (Acupuncture) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Week 12 - Baseline EORTC Autonomic Subscale | -0.3 score on a scale | Standard Deviation 1.1 |
| Group 2 (Usual Care) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Week 12 - EORTC Autonomic Subscale | 2.3 score on a scale | Standard Deviation 0.5 |
| Group 2 (Usual Care) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Baseline EORTC Subscale | 11.3 score on a scale | Standard Deviation 2.1 |
| Group 2 (Usual Care) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Baseline EORTC Autonomic Subscale | 2.8 score on a scale | Standard Deviation 0.8 |
| Group 2 (Usual Care) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Week 12 EORTC Subscale | 11.1 score on a scale | Standard Deviation 3.3 |
| Group 2 (Usual Care) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Week 12 - Baseline EORTC Autonomic Subscale | -0.5 score on a scale | Standard Deviation 0.9 |
| Group 2 (Usual Care) | Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20 | Week 12 - Baseline (Change) EORTC Subscale | -0.1 score on a scale | Standard Deviation 2.7 |
p-value: 0.91ANCOVA
p-value: 0.55ANCOVA
Secondary
Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling
Means and standard deviations will be computed at baseline and week 12 by group, and for the change in the measures, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome. The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period.
Time frame: Baseline up to week 12
Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Severity (Mild 2) | 6 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Severity (Mild 2) | 3 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Severity (Moderate 3) | 2 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Severity (Severe 4) | 1 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Severity (Very severe 5) | 0 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Severity (None 1) | 1 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Severity (None 1) | 4 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Severity (Moderate 3) | 2 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Severity (Severe 4) | 0 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Severity (Very severe 5) | 0 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Interference - Not at all (1) | 4 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Interference - A little bit (2) | 2 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Interference - Somewhat (3) | 2 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Interference -Quite a bit (4) | 2 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Interference - Very much (5) | 0 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Interference - Not at all (1) | 3 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Interference - A little bit (2) | 5 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Interference - Somewhat (3) | 1 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Interference - Quite a bit (4) | 0 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Interference - Very much (5) | 0 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Severity (Decreased, less than or equal to -1) | 5 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Severity - Same (0) | 3 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Severity (Increased, >/= 1) | 1 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Interference - (Decreased, </= -1) | 3 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Interference - (Same - 0) | 5 Participants |
| Group 1 (Acupuncture) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Interference - (Increased, >/= -1) | 1 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Interference - Very much (5) | 0 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Severity (None 1) | 2 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Interference -Quite a bit (4) | 2 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Severity (Mild 2) | 8 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Interference - (Same - 0) | 3 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Severity (Moderate 3) | 1 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Interference - Very much (5) | 0 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Severity (Severe 4) | 1 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Severity (Decreased, less than or equal to -1) | 7 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Severity (Very severe 5) | 0 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Interference - Not at all (1) | 7 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Severity (None 1) | 2 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Interference - (Decreased, </= -1) | 7 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Severity (Mild 2) | 4 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Interference - A little bit (2) | 1 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Severity (Moderate 3) | 3 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Severity - Same (0) | 1 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Severity (Severe 4) | 0 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Interference - Somewhat (3) | 3 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Severity (Very severe 5) | 0 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Interference - (Increased, >/= -1) | 1 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Interference - Not at all (1) | 1 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Numbness or Tingling Interference - Quite a bit (4) | 0 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Interference - A little bit (2) | 7 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Week 12 - Baseline (Change) Numbness or Tingling Severity (Increased, >/= 1) | 3 Participants |
| Group 2 (Usual Care) | Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling | Baseline - Numbness or Tingling Interference - Somewhat (3) | 2 Participants |
p-value: 0.55Fisher Exact
p-value: 0.41Fisher Exact
p-value: 0.22Fisher Exact
p-value: 0.58Fisher Exact
p-value: 0.12Fisher Exact
p-value: 0.57Fisher Exact
Secondary
CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling
The CTCAE measure of CIPN will be assessed using frequencies of grade by time point (baseline, week 12), as well as whether the grade of CIPN increased, decreased or remained stable. A Fisher's Exact test will be used to compare the groups at each time point and for the change during the study period.
Time frame: Up to week 12
Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (Acupuncture) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Baseline - Grade 2 Numbness or Tingling | 1 Participants |
| Group 1 (Acupuncture) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 Grade 3 Numbness or Tingling | 0 Participants |
| Group 1 (Acupuncture) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 - Grade 1 Numbness or Tingling | 7 Participants |
| Group 1 (Acupuncture) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 - Baseline Numbness or Tingling Severity Decreased (</= 1) | 0 Participants |
| Group 1 (Acupuncture) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Baseline - Grade 3 Numbness or Tingling | 0 Participants |
| Group 1 (Acupuncture) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 - Baseline Numbness or Tingling Severity Same (0) | 7 Participants |
| Group 1 (Acupuncture) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 Grade 2 Numbness or Tingling | 1 Participants |
| Group 1 (Acupuncture) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 - Baseline Numbness or Tingling Severity Increased (>/= 1) | 1 Participants |
| Group 1 (Acupuncture) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Baseline - Grade 1 Numbness or Tingling | 10 Participants |
| Group 2 (Usual Care) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 - Baseline Numbness or Tingling Severity Increased (>/= 1) | 2 Participants |
| Group 2 (Usual Care) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Baseline - Grade 1 Numbness or Tingling | 10 Participants |
| Group 2 (Usual Care) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Baseline - Grade 2 Numbness or Tingling | 2 Participants |
| Group 2 (Usual Care) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Baseline - Grade 3 Numbness or Tingling | 0 Participants |
| Group 2 (Usual Care) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 - Grade 1 Numbness or Tingling | 9 Participants |
| Group 2 (Usual Care) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 Grade 2 Numbness or Tingling | 1 Participants |
| Group 2 (Usual Care) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 Grade 3 Numbness or Tingling | 1 Participants |
| Group 2 (Usual Care) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 - Baseline Numbness or Tingling Severity Decreased (</= 1) | 0 Participants |
| Group 2 (Usual Care) | CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling | Week 12 - Baseline Numbness or Tingling Severity Same (0) | 9 Participants |
p-value: 0.99Fisher Exact
p-value: 0.99Fisher Exact
p-value: 0.99Fisher Exact
Secondary
Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Time frame: Up to week 12
Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. Two participants in the intervention group discontinued the intervention/treatment earlier than the anticipated 12 weeks time frame.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Acupuncture) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Velocity Sural | 50.5 meters per second | Standard Deviation 5.6 |
| Group 1 (Acupuncture) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline - Velocity Tibial (Change) | 2.1 meters per second | Standard Deviation 4.3 |
| Group 1 (Acupuncture) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Velocity Tibial | 49.1 meters per second | Standard Deviation 3.3 |
| Group 1 (Acupuncture) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Velocity Median | 55.5 meters per second | Standard Deviation 3.7 |
| Group 1 (Acupuncture) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline Velocity Sural (Change) | -1.0 meters per second | Standard Deviation 6.6 |
| Group 1 (Acupuncture) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | 12 Weeks - Velocity Median | 55.3 meters per second | Standard Deviation 5.9 |
| Group 1 (Acupuncture) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Velocity Tibial | 51.1 meters per second | Standard Deviation 5.6 |
| Group 1 (Acupuncture) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline - Velocity Median (Change) | -0.6 meters per second | Standard Deviation 5.3 |
| Group 1 (Acupuncture) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Velocity Sural | 51.1 meters per second | Standard Deviation 3 |
| Group 2 (Usual Care) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline - Velocity Median (Change) | 0.1 meters per second | Standard Deviation 2.9 |
| Group 2 (Usual Care) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Velocity Sural | 45.9 meters per second | Standard Deviation 3.8 |
| Group 2 (Usual Care) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Velocity Sural | 48.7 meters per second | Standard Deviation 4.2 |
| Group 2 (Usual Care) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline Velocity Sural (Change) | 2.2 meters per second | Standard Deviation 3.6 |
| Group 2 (Usual Care) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Velocity Tibial | 50.3 meters per second | Standard Deviation 5.1 |
| Group 2 (Usual Care) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Velocity Tibial | 49.4 meters per second | Standard Deviation 5.4 |
| Group 2 (Usual Care) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline - Velocity Tibial (Change) | -2.0 meters per second | Standard Deviation 2.3 |
| Group 2 (Usual Care) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Velocity Median | 54.2 meters per second | Standard Deviation 4.1 |
| Group 2 (Usual Care) | Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median) | 12 Weeks - Velocity Median | 55.5 meters per second | Standard Deviation 2.8 |
p-value: 0.98ANCOVA
p-value: 0.03ANCOVA
p-value: 0.81ANCOVA
Secondary
Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Time frame: Up to week 12
Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention. Treatment ended early for 2 participants in the intervention group, discontinued the intervention
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Acupuncture) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Baseline - Cross sectional area - sural | 3.1 meters squared | Standard Deviation 1.5 |
| Group 1 (Acupuncture) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Baseline - Cross sectional area - median | 14.2 meters squared | Standard Deviation 6.3 |
| Group 1 (Acupuncture) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Week 12 - Cross sectional area - sural | 3.0 meters squared | Standard Deviation 1.3 |
| Group 1 (Acupuncture) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Week 12 - Cross sectional area - median | 14.6 meters squared | Standard Deviation 7.5 |
| Group 1 (Acupuncture) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Week 12 - Baseline - Cross sectional area - sural (Change) | -0.4 meters squared | Standard Deviation 1 |
| Group 1 (Acupuncture) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Week 12 - Baseline - Cross sectional area - median (Change) | 0.1 meters squared | Standard Deviation 1.5 |
| Group 2 (Usual Care) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Week 12 - Baseline - Cross sectional area - sural (Change) | 0.1 meters squared | Standard Deviation 1.3 |
| Group 2 (Usual Care) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Baseline - Cross sectional area - sural | 2.8 meters squared | Standard Deviation 0.7 |
| Group 2 (Usual Care) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Week 12 - Cross sectional area - median | 11.9 meters squared | Standard Deviation 2.8 |
| Group 2 (Usual Care) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Baseline - Cross sectional area - median | 12.7 meters squared | Standard Deviation 3.3 |
| Group 2 (Usual Care) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Week 12 - Baseline - Cross sectional area - median (Change) | -1.0 meters squared | Standard Deviation 2 |
| Group 2 (Usual Care) | Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median) | Week 12 - Cross sectional area - sural | 3.0 meters squared | Standard Deviation 1.2 |
p-value: 0.46ANCOVA
p-value: 0.22ANCOVA
Secondary
Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Time frame: Up to week 12
Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Latency tibial, ankle | 3.6 milliseconds | Standard Deviation 0.5 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline Latency tibial, pop | -0.2 milliseconds | Standard Deviation 0.6 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Latency Sural | 3.4 milliseconds | Standard Deviation 0.6 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Latency median wrist | 4.0 milliseconds | Standard Deviation 1.1 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline Latency tibial, ankle (Change) | -0.1 milliseconds | Standard Deviation 0.8 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Latency median wrist | 4.4 milliseconds | Standard Deviation 1.9 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Latency tibial, ankle | 3.6 milliseconds | Standard Deviation 0.3 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline Latency median wrist (Change | 0.5 milliseconds | Standard Deviation 1 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Latency tibial, pop | 11.5 milliseconds | Standard Deviation 1 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Latency median elbow | 7.8 milliseconds | Standard Deviation 1.5 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 -Baseline - Latency Sural (Change) | 0.0 milliseconds | Standard Deviation 0.7 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Latency median elbow | 8.2 milliseconds | Standard Deviation 2.5 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Latency tibial, pop | 11.2 milliseconds | Standard Deviation 1.1 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline - Latency median elbow (Change) | 0.4 milliseconds | Standard Deviation 1.2 |
| Group 1 (Acupuncture) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Latency Sural | 3.4 milliseconds | Standard Deviation 0.6 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline - Latency median elbow (Change) | 0.0 milliseconds | Standard Deviation 0.6 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Latency Sural | 3.4 milliseconds | Standard Deviation 0.6 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Latency Sural | 3.3 milliseconds | Standard Deviation 0.6 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 -Baseline - Latency Sural (Change) | 0.0 milliseconds | Standard Deviation 0.3 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Latency tibial, ankle | 4.0 milliseconds | Standard Deviation 0.5 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Latency tibial, ankle | 3.8 milliseconds | Standard Deviation 0.6 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline Latency tibial, ankle (Change) | -0.2 milliseconds | Standard Deviation 0.4 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Latency tibial, pop | 11.7 milliseconds | Standard Deviation 1.2 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Latency tibial, pop | 11.5 milliseconds | Standard Deviation 1.2 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline Latency tibial, pop | 0.1 milliseconds | Standard Deviation 0.4 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Latency median wrist | 3.7 milliseconds | Standard Deviation 0.5 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Latency median wrist | 3.7 milliseconds | Standard Deviation 0.5 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Baseline Latency median wrist (Change | -0.1 milliseconds | Standard Deviation 0.4 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Baseline - Latency median elbow | 7.5 milliseconds | Standard Deviation 0.7 |
| Group 2 (Usual Care) | Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median) | Week 12 - Latency median elbow | 7.5 milliseconds | Standard Deviation 0.7 |
p-value: 0.81ANCOVA
p-value: 0.76ANCOVA
p-value: 0.24ANCOVA
p-value: 0.2ANCOVA
p-value: 0.51ANCOVA
Secondary
Nerve Fiber Density in the Skin
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Time frame: Up to week 12
Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 (Acupuncture) | Nerve Fiber Density in the Skin | Baseline - Nerve fiber density, distal leg | 7.8 fibers per millimeter | Standard Deviation 3.2 |
| Group 1 (Acupuncture) | Nerve Fiber Density in the Skin | Week 12 - Nerve fiber density, distal leg | 3.5 fibers per millimeter | Standard Deviation 0.7 |
| Group 1 (Acupuncture) | Nerve Fiber Density in the Skin | Week 12 - Baseline - Nerve fiber density, distal leg | -5.1 fibers per millimeter | Standard Deviation 2.8 |
| Group 2 (Usual Care) | Nerve Fiber Density in the Skin | Baseline - Nerve fiber density, distal leg | 8.3 fibers per millimeter | Standard Deviation 3.3 |
| Group 2 (Usual Care) | Nerve Fiber Density in the Skin | Week 12 - Nerve fiber density, distal leg | 4.3 fibers per millimeter | Standard Deviation 1.7 |
| Group 2 (Usual Care) | Nerve Fiber Density in the Skin | Week 12 - Baseline - Nerve fiber density, distal leg | -4.5 fibers per millimeter | Standard Deviation 3 |
Secondary
Number of Cycles of Completed Chemotherapy
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points, and fit ANCOVA models for each outcome.
Time frame: Up to week 12
Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1 (Acupuncture) | Number of Cycles of Completed Chemotherapy | 4.4 cycles | Standard Deviation 0.7 |
| Group 2 (Usual Care) | Number of Cycles of Completed Chemotherapy | 4.2 cycles | Standard Deviation 1 |
p-value: 0.69t-test, 2 sided
Secondary
Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy
Means and standard deviations will be computed at baseline and week 12 by group, and will also estimate the correlation between the measures at the two time points
Time frame: Up to week 12
Population: Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Group 1 (Acupuncture) | Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy | Chemotherapy dose standard | 6 Participants |
| Group 1 (Acupuncture) | Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy | Chemotherapy dose decreased due to chemotherapy induced peripheral neuropathy | 3 Participants |
| Group 2 (Usual Care) | Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy | Chemotherapy dose standard | 7 Participants |
| Group 2 (Usual Care) | Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy | Chemotherapy dose decreased due to chemotherapy induced peripheral neuropathy | 3 Participants |
p-value: 0.99Fisher Exact