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

Dana-Farber Cancer Institute

Status: Active, not recruiting

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

Treatments: Device: Acupuncture; Other: Nature scenery with a relaxation exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT05528263

22-269

Details and patient eligibility

About

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.

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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89 participants in 2 patient groups

Acupuncture

Experimental group

Description:

* 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).

Treatment:

Device: Acupuncture

Nature scenery videos with relaxation exercise

Active Comparator group

Description:

* 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)

Treatment:

Other: Nature scenery with a relaxation exercise