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

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

NCT ID: NCT05528263

Condition: Acupuncture
Early-stage Breast Cancer
Chemotherapy-induced Peripheral Neuropathy
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III

Conditions: Official terms:
Breast Neoplasms
Peripheral Nervous System Diseases

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

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Supportive Care

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Acupuncture
Description: Standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions).
Arm group label: Acupuncture

Intervention type: Other
Intervention name: Nature scenery with a relaxation exercise
Description: Watch nature scenery videos with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions)
Arm group label: Nature scenery videos with relaxation exercise

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Dana Farber Cancer Institute

Address:
City: Boston
Zip: 02215
Country: United States

Status: Recruiting

Contact:
Last name: Anna M Tanasijevic

Phone: 617-632-5584
Email: anna_tanasijevic@dfci.harvard.edu

Contact backup:
Last name: Ellie Diederich

Phone: 617-632-5408
Email: Ellie_Diederich@DFCI.HARVARD.EDU

Investigator:
Last name: Weidong Lu, PhD, MPH
Email: Principal Investigator

Start date: September 8, 2022

Completion date: February 28, 2026

Lead sponsor:
Agency: Dana-Farber Cancer Institute
Agency class: Other

Collaborator:
Agency: The Comprehensive and Integrative Medicine Institute of South Korea
Agency class: Other

Source: Dana-Farber Cancer Institute

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05528263