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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

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

PACT Trial Summary

This trial is studying whether acupuncture can help prevent or lessen chemotherapy-induced peripheral neuropathy in people with breast cancer. It will also study if it improves quality of life. Funding is provided by CIMI of S.Korea.

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.Check my eligibility

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.See study design

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.

PACT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am about to start or have just started taxane-based chemotherapy for my cancer.

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I am 18 years old or older.

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I am fully active or can carry out light work.

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I had breast cancer at stage I-III and it hasn't spread far.

PACT Trial 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

This trial's timeline: 3 weeks for screening, Varies for treatment, and pre-treatment, and at weeks 3, 6, 9, and 12 during the intervention up to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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 more

Side effects data

From 2013 Phase 1 & 2 trial • 104 Patients • NCT01305811

Serious unexpected

Pain on needling

100%

80%

60%

40%

20%

Study treatment Arm

Bi-Weekly Acupuncture

Wait List

PACT 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

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

The Comprehensive and Integrative Medicine Institute of South KoreaOTHER

3 Previous Clinical Trials

140 Total Patients Enrolled

Dana-Farber Cancer InstituteLead Sponsor

1,079 Previous Clinical Trials

340,900 Total Patients Enrolled

Weidong Lu, MB, MPH, PhDPrincipal InvestigatorDana-Farber Cancer Institute

2 Previous Clinical Trials

68 Total Patients Enrolled

Media Library

Acupuncture Clinical Trial Eligibility Overview. Trial Name: NCT05528263 — N/A

Peripheral Neuropathy Research Study Groups: Acupuncture, Nature scenery videos with relaxation exercise

Peripheral Neuropathy Clinical Trial 2023: Acupuncture Highlights & Side Effects. Trial Name: NCT05528263 — N/A

Acupuncture 2023 Treatment Timeline for Medical Study. Trial Name: NCT05528263 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of this clinical investigation?

"Affirmative, the details present on clinicaltrials.gov indicate that recruitment for this experiment is underway. It was initially posted to the website September 8th 2022 and has been subsequently updated December 21st of same year. The aim is to find 80 patients from a single site."

Answered by AI

Are there any remaining vacancies for participants in this clinical study?

"Correct. According to the information presented on clinicaltrials.gov, this medical trial is in search of 80 participants from a single location and was first advertised on September 8th 2022 with its most recent update made December 21st 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Weidong Lu, MB, MPH, PhD 2022. "Preventing Chemotherapy-Induced Peripheral Neuropathy With Acupuncture (PACT Trial)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05528263.

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