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Acupuncture for Chemotherapy-Induced Peripheral Neuropathy (PACT Trial)
N/A
Recruiting
Led By Weidong Lu, MB, MPH, PhD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Must not have
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
History of pre-existing peripheral neuropathy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether acupuncture or relaxation exercises can reduce symptoms like pain and numbness in breast cancer patients undergoing taxane-based chemotherapy. The goal is to improve their quality of life by alleviating these side effects. Acupuncture has been used to manage cancer pain and improve quality of life in cancer patients.
Who is the study for?
This trial is for adults over 18 with stage I-III breast cancer, scheduled for taxane-based chemo without prior CIPN-inducing treatment or severe heart issues. They must have good performance status and no history of acupuncture use in the last 3 months.
What is being tested?
The PACT Trial is testing if acupuncture can prevent or reduce chemotherapy-induced peripheral neuropathy (CIPN) compared to watching nature videos with relaxation exercises in patients receiving taxane-based chemotherapy.
What are the potential side effects?
Acupuncture may cause minor bruising, bleeding at needle sites, fatigue, dizziness or rare serious side effects like infections. The relaxation exercise group should not experience significant side effects.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am about to start or have just started taxane-based chemotherapy for my cancer.
Select...
I am 18 years old or older.
Select...
I am fully active or can carry out light work.
Select...
I had breast cancer at stage I-III and it hasn't spread far.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have symptoms of nerve damage from chemotherapy.
Select...
I have a history of nerve damage in my hands or feet.
Select...
I have seizures that are not controlled by medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in severity of CIPN, defined by mean change in EORTC QLQ-CIPN20 sensory score
Secondary study objectives
Changes in mean scores of pain intensity
Changes in the total and subscales of EORTC QLQ-C30
Changes in the total mean scores of the Pittsburgh Sleep Quality Index (PSQI)
+4 moreSide effects data
From 2013 Phase 1 & 2 trial • 104 Patients • NCT013058112%
Serious unexpected
2%
Pain on needling
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bi-Weekly Acupuncture
Wait List
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: AcupunctureExperimental Treatment1 Intervention
* 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).
Group II: Nature scenery videos with relaxation exerciseActive Control1 Intervention
* 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
First Studied
Drug Approval Stage
How many patients have taken this drug
Acupuncture
2011
Completed Phase 3
~1240
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Peripheral neuropathy treatments, such as acupuncture, TENS, and scrambler therapy, aim to alleviate pain and improve nerve function by modulating nerve signals. Acupuncture involves stimulating specific points on the body, which may increase blood flow, release endorphins, and modulate the nervous system.
TENS and scrambler therapy use electrical stimulation to alter pain signals. These mechanisms are important for patients to understand as they provide insight into how these treatments can help manage symptoms and improve quality of life.
Find a Location
Who is running the clinical trial?
The Comprehensive and Integrative Medicine Institute of South KoreaOTHER
3 Previous Clinical Trials
144 Total Patients Enrolled
1 Trials studying Breast Cancer
84 Patients Enrolled for Breast Cancer
Dana-Farber Cancer InstituteLead Sponsor
1,109 Previous Clinical Trials
357,218 Total Patients Enrolled
145 Trials studying Breast Cancer
20,205 Patients Enrolled for Breast Cancer
Weidong Lu, MB, MPH, PhDPrincipal InvestigatorDana-Farber Cancer Institute
2 Previous Clinical Trials
68 Total Patients Enrolled
1 Trials studying Breast Cancer
26 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have symptoms of nerve damage from chemotherapy.I have a history of nerve damage in my hands or feet.I am about to start or have just started taxane-based chemotherapy for my cancer.I have not had a heart attack or unstable heart condition in the last 6 months.I have had chemotherapy that can cause nerve damage, but only one dose of taxane.I have not used acupuncture in the last 3 months.You have a pacemaker or implantable cardioverter-defibrillator.I am 18 years old or older.I have seizures that are not controlled by medication.I am fully active or can carry out light work.I had breast cancer at stage I-III and it hasn't spread far.
Research Study Groups:
This trial has the following groups:- Group 1: Acupuncture
- Group 2: Nature scenery videos with relaxation exercise
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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