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

Completed · Not applicable

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

In brief

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.

Key facts

Study ID

NCT05528263

Run by

Dana-Farber Cancer Institute

People needed

89

Starts

2022-09-08

Expected to finish

2025-05-30

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Dana Farber Cancer Institute — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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