Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)

Study Overview
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Brief Summary
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This research is being done to determine whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy (CIPN), a side effect of some kinds of chemotherapy that causes pain, numbness, tingling, swelling, or muscle weakness mostly in the hands or feet. This research will also help determine whether acupuncture can improve quality of life in patients receiving taxane-based chemotherapy for the treatment of breast cancer. The names of the study activities involved in this study are/is: Acupuncture treatments for participants in the Acupuncture Group Nature videos with a relaxation exercise for participants in the Relaxation/ Exercise Group The Comprehensive and Integrative Medicine Institute (CIMI) of South Korea is supporting this research study by providing funding.

Detailed Description
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This study randomly assigns patients with breast cancer who are starting a chemotherapy program that includes a Taxane to one of two groups: The Acupuncture Group will receive acupuncture treatments for 12 weeks during chemotherapy treatment. The Relaxation Exercise Group will receive a program of weekly videos accompanied by a relaxation exercise. Both programs will last 12 weeks. Participants will be asked to complete questionnaire 12 weeks after the completion of the acupuncture or relaxation exercise program, so participants be on this research study for up to 24 weeks (6 months). It is expected that about 80 people will take part in this research study.

Official Title
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Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture, A Randomized Controlled Trial (PACT Trial)

Conditions
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Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III

Intervention / Treatment
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* Device: Acupuncture
* Other: Nature scenery with a relaxation exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: History of histologically proven stage I-III breast cancer, without evidence of distant metastasis Scheduled to receive adjuvant or neoadjuvant taxane-based chemotherapy (with or without HER-2 directed therapy or with or without immunotherapy). Patient must enroll before the second infusion of a taxane. Age ≥ 18 years Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Signed informed consent Exclusion Criteria: Previous receipt of CIPN-inducing chemotherapy agents (1 prior dose of a taxane is allowed). Unstable cardiac disease or myocardial infarction within 6 months prior to study entry Wearing a pacemaker or implantable cardioverter-defibrillator Uncontrolled seizure disorder History of pre-existing peripheral neuropathy Use of acupuncture within the 3 months prior to study enrollment Self-report of any CIPN symptoms via staff-administered PRO-CTCAE CIPN, defined as either: Report of mild, moderate, severe, very severe on the Severity Item on PRO-CTCAE CIPN assessment Report of a little bit, somewhat, quite a bit, very much on the Interfere Item on PRO-CTCAE CIPN assessment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br>Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline. 40 participants will be randomized into the acupuncture Arm: The acupuncture arm will receive a standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions). | Device: Acupuncture<br>* Standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions).<br>|
| Active Comparator: Nature scenery videos with relaxation exercise<br>Breast cancer patients will be recruited who are scheduled to receive taxane-based chemotherapy (with or without anti-HER2 therapy) and who have no neuropathic symptoms at baseline. 40 Participants will be randomized into the Control Arm: The control arm will receive and watch videos with nature scenery with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions) | Other: Nature scenery with a relaxation exercise<br>* Watch nature scenery videos with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score | The primary endpoint is the change in severity of CIPN, defined as the average change from baseline (12-week to baseline) in the EORTC Quality of Life - Chemotherapy Induced Neuropathy 20 (QLQ-CIPN20) sensory subscale score (9 items). 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. A higher score means greater severity of CIPN. The total and three domain scores are calculated and linearly transformed into 0-100 scales according to the scoring manual. A score of 100 indicates the worst CIPN symptom. | baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of CIPN between intervention arms - AOCIPN | AOCIPN is defined as an increase of 2.5 points or larger in the QLQ-CIPN 20 sensory score at any time point relative to baseline or reported mild or a little bit or higher in PRO-CTCAE CIPN Severity and Interference items during the study intervention period (baseline to week 12). | baseline to week 12 | 
| Incidence of CIPN between intervention arms - G2CIPN | G2CIPN is defined a 20-point or greater increase from baseline at any time point in QLQ-CIPN20 total score or grade-2 in PRO-CTCAE CIPN, which is defined as reporting the severity of numbness and/or tingling AND interference of with daily activities ≥ 1 (mild/ a little bit) during the study period at any time point. | baseline to 12 Weeks | 
| Relative dose intensity (RDI) | Received or relative dose intensity (RDI) refers to the amount and timing of chemotherapy actually delivered versus the expected dose and schedule. The relative dose intensity (RDI) will be calculated for each participant and compared between treatment arms using two-sample t-tests or Wilcoxon rank-sum tests, depending upon normality of the data. | baseline to week 24 | 
| Maximum CIPN score | Maximum CIPN score will be assessed through the EORTC Quality of Life - Chemotherapy Induced Neuropathy 20 (QLQ-CIPN20) sensory subscale score (9 items). 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. A higher score means greater severity of CIPN. The maximum CIPN sensory score change (post-pre) for each patient during the intervention will be compared between the randomized treatment arms. | pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks | 
| Changes in mean scores of pain intensity | CIPN pain intensity will be measured using a past 7 days, 0-10 numerical rating scale diary. A higher score indicates greater pain intensity. | Baseline, Week 12, and Week 24 | 
| Changes in the total mean scores of the Pittsburgh Sleep Quality Index (PSQI) | The PSQI is a 19-item self-reported questionnaire that assesses sleep quality for the preceding month. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality. | Baseline, Week 12, and Week 24 | 
| Changes in the total and subscales of EORTC QLQ-C30 | Quality of life and cancer treatment-related symptoms will be assessed using the EORTC-QLQ-C30. The QLQ-C30 consists of 30 items that are grouped within global health status/quality of life (1 - 7 points, higher scores = greater quality of life), functional (e.g., physical or cognitive; 0 - 100 transformed scores, higher = better function), or symptom (e.g., insomnia, fatigue; 0 - 100 transformed scores, higher = worse symptoms) subscales. | Baseline, Week 12, and Week 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture, Early-stage Breast Cancer, Chemotherapy-induced Peripheral Neuropathy, Breast Cancer Stage I, Breast Cancer Stage II, Breast Cancer Stage III