Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Nervous System Diseases

Breast Neoplasms

Peripheral Nervous System Diseases

Neuritis

Breast Diseases

Skin Diseases

Neuromuscular Diseases

Participants undergo 8 45-minute acupuncture treatments over 10 weeks.

Acupuncture Therapy

Best Practice

Quality-of-Life Assessment

Questionnaire Administration

Nancy Avis

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.

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.

Acupuncture in Reducing Chemotherapy-Induced Peripheral Neuropathy in Participants With Stage I-III Breast Cancer

Acupuncture for Chemotherapy-Induced Peripheral Neuropathy Among Breast Cancer Patients

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.

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.

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.

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.

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

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.

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.

National Cancer Institute (NCI)

Wake Forest University Health Sciences

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

Group 1 (Acupuncture)

Participants receive usual care.

Best Practice: Receive usual care

Quality-of-Life Assessment: Ancillary studies

Questionnaire Administration: Ancillary studies

Group 2 (Usual Care)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Nancy Avis, PhD

Baseline

Week 12

Week 12 - Baseline (Change)

Number of participants analyzed may differ due to participants being lost to follow up or withdrawing from intervention.

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 EORTC Subscale

Week 12 EORTC Subscale

Week 12 - Baseline (Change) EORTC Subscale

Baseline EORTC Autonomic Subscale

Week 12 - EORTC Autonomic Subscale

Week 12 - Baseline EORTC Autonomic Subscale

Change in Motor and Autonomic Pain Subscores on the EORTC QLQ-CIPN20

Baseline - Numbness or Tingling Severity (None 1)

Baseline - Numbness or Tingling Severity (Mild 2)

Baseline - Numbness or Tingling Severity (Moderate 3)

Baseline - Numbness or Tingling Severity (Severe 4)

Baseline - Numbness or Tingling Severity (Very severe 5)

Week 12 - Numbness or Tingling Severity (None 1)

Week 12 - Numbness or Tingling Severity (Mild 2)

Week 12 - Numbness or Tingling Severity (Moderate 3)

Week 12 - Numbness or Tingling Severity (Severe 4)

Week 12 - Numbness or Tingling Severity (Very severe 5)

Baseline - Numbness or Tingling Interference - Not at all (1)

Baseline - Numbness or Tingling Interference - A little bit (2)

Baseline - Numbness or Tingling Interference - Somewhat (3)

Baseline - Numbness or Tingling Interference -Quite a bit (4)

Baseline - Numbness or Tingling Interference - Very much (5)

Week 12 - Numbness or Tingling Interference - Not at all (1)

Week 12 - Numbness or Tingling Interference - A little bit (2)

Week 12 - Numbness or Tingling Interference - Somewhat (3)

Week 12 - Numbness or Tingling Interference - Quite a bit (4)

Week 12 - Numbness or Tingling Interference - Very much (5)

Week 12 - Baseline (Change) Numbness or Tingling Severity (Decreased, less than or equal to -1)

Week 12 - Baseline (Change) Numbness or Tingling Severity - Same (0)

Week 12 - Baseline (Change) Numbness or Tingling Severity (Increased, >/= 1)

Week 12 - Baseline (Change) Numbness or Tingling Interference - (Decreased, </= -1)

Week 12 - Baseline (Change) Numbness or Tingling Interference - (Same - 0)

Week 12 - Baseline (Change) Numbness or Tingling Interference - (Increased, >/= -1)

Change in Patient-Reported Outcomes (PRO)-Common Terminology Criteria for Adverse Events (CTCAE) Measure of Numbness and Tingling

Baseline - Grade 1 Numbness or Tingling

Baseline - Grade 2 Numbness or Tingling

Baseline - Grade 3 Numbness or Tingling

Week 12 - Grade 1 Numbness or Tingling

Week 12 Grade 2 Numbness or Tingling

Week 12 Grade 3 Numbness or Tingling

Week 12 - Baseline Numbness or Tingling Severity Decreased (</= 1)

Week 12 - Baseline Numbness or Tingling Severity Same (0)

Week 12 - Baseline Numbness or Tingling Severity Increased (>/= 1)

CIPN as Measured by National Cancer Institute (NCI)-CTCAE 5.0 Grades 1-3 Numbness or Tingling

Chemotherapy dose standard

Chemotherapy dose decreased due to chemotherapy induced peripheral neuropathy

Number of Participants With Standard Chemotherapy Dose or Decreased Due to Peripheral Neuropathy

Number of Cycles of Completed Chemotherapy

Baseline - Cross sectional area - sural

Baseline - Cross sectional area - median

Week 12 - Cross sectional area - sural

Week 12 - Cross sectional area - median

Week 12 - Baseline - Cross sectional area - sural (Change)

Week 12 - Baseline - Cross sectional area - median (Change)

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

Cross Sectional Area (CSA) of Peripheral Nerves as Determined by Ultrasound (Sural and Median)

Baseline - Amplitude (sural)

Week 12 - Amplitude (sural)

Week 12 - Baseline Amplitude (sural)

Baseline - Amplitude - Tibial, ankle

Week 12 - Amplitude - Tibial, ankle

Week 12 - Baseline - Amplitude - Tibial, ankle (Change)

Baseline - Amplitude - Tibial, pop fossa

Week 12 - Amplitude - Tibial, pop fossa

Week 12 - Baseline - Amplitude - Tibial, pop fossa (Change)

Baseline - Amplitude - median, wrist

Week 12 - Amplitude - median, wrist

Week 12 - Baseline - Amplitude - median, wrist (Change)

Baseline - Amplitude - median, elbow

Week 12 - Amplitude - median, elbow

Week 12 - Baseline Amplitude - median, elbow (Change)

Amplitude of Nerve Response Derived From Nerve Conduction Studies (NCS) (Sural, Tibial, and Median)

Baseline - Latency Sural

Week 12 - Latency Sural

Week 12 -Baseline - Latency Sural (Change)

Baseline - Latency tibial, ankle

Week 12 - Latency tibial, ankle

Week 12 - Baseline Latency tibial, ankle (Change)

Baseline - Latency tibial, pop

Week 12 - Latency tibial, pop

Week 12 - Baseline Latency tibial, pop

Baseline - Latency median wrist

Week 12 - Latency median wrist

Week 12 - Baseline Latency median wrist (Change

Baseline - Latency median elbow

Week 12 - Latency median elbow

Week 12 - Baseline - Latency median elbow (Change)

Distal Latency of Nerve Response Derived From NCS (Sural, Tibial, and Median)

Baseline - Velocity Sural

Week 12 - Velocity Sural

Week 12 - Baseline Velocity Sural (Change)

Baseline - Velocity Tibial

Week 12 - Velocity Tibial

Week 12 - Baseline - Velocity Tibial (Change)

Baseline - Velocity Median

12 Weeks - Velocity Median

Week 12 - Baseline - Velocity Median (Change)

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.

Conduction Velocity of Nerve Response Derived From NCS (Sural, Tibial, and Median)

Spots Global Cancer Trial Database for grade 2 peripheral motor neuropathy, ctcae