NCT05528263

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 89 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DEVICE	Acupuncture	Standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions).
OTHER	Nature scenery with a relaxation exercise	Watch nature scenery videos with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions)

Timeline

• Start date: 2022-09-08
• Primary completion: 2025-05-30
• Completion: 2025-05-30
• First posted: 2022-09-06
• Last updated: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study