Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture, A Randomized Controlled Trial (PACT Trial)
Overview
- Phase
- Not Applicable
- Intervention
- Acupuncture
- Conditions
- Acupuncture
- Sponsor
- Dana-Farber Cancer Institute
- Enrollment
- 89
- Locations
- 1
- Primary Endpoint
- Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
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
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.
Investigators
Weidong Lu, MB, MPH, PhD
Principal Investigator
Dana-Farber Cancer Institute
Eligibility Criteria
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
Arms & Interventions
Acupuncture
* 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).
Intervention: Acupuncture
Nature scenery videos with relaxation exercise
* 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)
Intervention: Nature scenery with a relaxation exercise
Outcomes
Primary Outcomes
Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score
Time Frame: baseline to 12 weeks
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.
Secondary Outcomes
- Incidence of CIPN between intervention arms - AOCIPN(baseline to week 12)
- Relative dose intensity (RDI)(baseline to week 24)
- Incidence of CIPN between intervention arms - G2CIPN(baseline to 12 Weeks)
- Maximum CIPN score(pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks)
- Changes in mean scores of pain intensity(Baseline, Week 12, and Week 24)
- Changes in the total mean scores of the Pittsburgh Sleep Quality Index (PSQI)(Baseline, Week 12, and Week 24)
- Changes in the total and subscales of EORTC QLQ-C30(Baseline, Week 12, and Week 24)