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

NCT05528263 | Completed DMC FDA Device

• 1 other identifier: 22-269
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score

  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.

  baseline to 12 weeks

Secondary Outcomes (7)

• Incidence of CIPN between intervention arms - AOCIPN

  baseline to week 12

• Incidence of CIPN between intervention arms - G2CIPN

  baseline to 12 Weeks

• Relative dose intensity (RDI)

  baseline to week 24

• 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

Study Arms (2)

Acupuncture

EXPERIMENTAL

* 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).

Device: Acupuncture

Nature scenery videos with relaxation exercise

ACTIVE COMPARATOR

* 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)

Other: Nature scenery with a relaxation exercise

Interventions

Acupuncture DEVICE

Standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions).

Acupuncture

Nature scenery with a relaxation exercise OTHER

Watch nature scenery videos with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions)

Nature scenery videos with relaxation exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• The Comprehensive and Integrative Medicine Institute of South Korea: collaborator

Study Sites (1)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Acupuncture Therapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Weidong Lu, MB, MPH, PhD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 6, 2022
• Study Start: September 8, 2022
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: February 24, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)