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

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer Stage I; Breast Cancer Stage II; Acupuncture; Breast Cancer Stage III; Chemotherapy-induced Peripheral Neuropathy; Early-stage Breast Cancer
• Intervention / Treatment: Device: Acupuncture; Other: Nature scenery with a relaxation exercise

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.

• Study Type: Interventional
• Enrollment (Actual): 89
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Acupuncture; 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; Standardized acupuncture protocol 1-2 times a week for 12 weeks (a total of 14 sessions).
Active Comparator: Nature scenery videos with relaxation exercise; 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; Watch nature scenery videos with a relaxation exercise guide 1-2 times a week for 12 weeks (a total of 14 sessions)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of CIPN between intervention arms - AOCIPN	AOCIPN is defined as an increase of 2.5 points or larger in the QLQ-CIPN 20 sensory score at any time point relative to baseline or reported "mild" or "a little bit" or higher in PRO-CTCAE CIPN "Severity" and "Interference" items during the study intervention period (baseline to week 12).	baseline to week 12
Incidence of CIPN between intervention arms - G2CIPN	G2CIPN is defined a 20-point or greater increase from baseline at any time point in QLQ-CIPN20 total score or grade-2 in PRO-CTCAE CIPN, which is defined as reporting the severity of numbness and/or tingling AND interference of with daily activities ≥ 1 (mild/ a little bit) during the study period at any time point.	baseline to 12 Weeks
Relative dose intensity (RDI)	Received or relative dose intensity (RDI) refers to the amount and timing of chemotherapy actually delivered versus the expected dose and schedule. The relative dose intensity (RDI) will be calculated for each participant and compared between treatment arms using two-sample t-tests or Wilcoxon rank-sum tests, depending upon normality of the data.	baseline to week 24
Maximum CIPN score	Maximum CIPN score will be assessed through 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 maximum CIPN sensory score change (post-pre) for each patient during the intervention will be compared between the randomized treatment arms.	pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks
Changes in mean scores of pain intensity	CIPN pain intensity will be measured using a past 7 days, 0-10 numerical rating scale diary. A higher score indicates greater pain intensity.	Baseline, Week 12, and Week 24
Changes in the total mean scores of the Pittsburgh Sleep Quality Index (PSQI)	The PSQI is a 19-item self-reported questionnaire that assesses sleep quality for the preceding month. In scoring the PSQI, seven component scores are derived, each scored 0 (no difficulty) to 3 (severe difficulty). The component scores are summed to produce a global score (range 0 to 21). Higher scores indicate worse sleep quality.	Baseline, Week 12, and Week 24
Changes in the total and subscales of EORTC QLQ-C30	Quality of life and cancer treatment-related symptoms will be assessed using the EORTC-QLQ-C30. The QLQ-C30 consists of 30 items that are grouped within global health status/quality of life (1 - 7 points, higher scores = greater quality of life), functional (e.g., physical or cognitive; 0 - 100 transformed scores, higher = better function), or symptom (e.g., insomnia, fatigue; 0 - 100 transformed scores, higher = worse symptoms) subscales.	Baseline, Week 12, and Week 24

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: The Comprehensive and Integrative Medicine Institute of South Korea
• Investigators: Principal Investigator: Weidong Lu, MB, MPH, PhD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): September 8, 2022
• Primary Completion (Actual): May 30, 2025
• Study Completion (Actual): May 30, 2025

Study Registration Dates

• First Submitted: August 29, 2022
• First Submitted That Met QC Criteria: September 2, 2022
• First Posted (Actual): September 6, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Acupuncture; Breast Cancer Stage I; Breast Cancer Stage II; Breast Cancer Stage III; Early-stage Breast Cancer; Chemotherapy-induced Peripheral Neuropathy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Therapeutics; Complementary Therapies; Acupuncture Therapy
• Other Study ID Numbers: 22-269

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes