Clinical trial NCT05528263: Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)
Official title: Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture, A Randomized Controlled Trial (PACT Trial)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acupuncture
Early-stage Breast Cancer
Chemotherapy-induced Peripheral Neuropathy
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Keywords: Acupuncture
Early-stage Breast Cancer
Chemotherapy-induced Peripheral Neuropathy
Breast Cancer Stage I
Breast Cancer Stage II
Breast Cancer Stage III
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: The Comprehensive and Integrative Medicine Institute of South Korea
First posted: 2022-09-06
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score
timeFrame: baseline to 12 weeks
Secondary outcomes:
measure: Incidence of CIPN between intervention arms - AOCIPN
timeFrame: baseline to week 12
measure: Incidence of CIPN between intervention arms - G2CIPN
timeFrame: baseline to 12 Weeks
measure: Relative dose intensity (RDI)
timeFrame: baseline to week 24
measure: Maximum CIPN score
timeFrame: pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks
measure: Changes in mean scores of pain intensity
timeFrame: Baseline, Week 12, and Week 24
measure: Changes in the total mean scores of the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, Week 12, and Week 24
measure: Changes in the total and subscales of EORTC QLQ-C30
timeFrame: Baseline, Week 12, and Week 24
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Weidong Lu, MB, MPH, PhD
role: PRINCIPAL_INVESTIGATOR
References: