What side effects are associated with this type of intervention?

Acupuncture and similar treatments for Peripheral Neuropathy, such as dry needling, intramuscular stimulation, and trigger point injections, are generally considered safe with minimal side effects. Common side effects may include minor bruising, soreness, or bleeding at the needle insertion sites. Transcutaneous Electrical Nerve Stimulation (TENS) and Scrambler therapy, other non-pharmacologic interventions, may cause mild skin irritation or discomfort at the electrode sites. Overall, these treatments are well-tolerated, but individual responses can vary.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of peripheral neuropathy, primarily focusing on pain management. These include gabapentin and pregabalin, which are commonly used to alleviate neuropathic pain. While acupuncture itself is not an FDA-approved treatment, it is being studied for its potential benefits in managing symptoms of peripheral neuropathy, such as in the PACT trial for chemotherapy-induced peripheral neuropathy. Other non-pharmacologic treatments like transcutaneous electrical nerve stimulation (TENS) and Scrambler therapy have shown promise in clinical settings but are not specifically FDA-approved for peripheral neuropathy.

What other types of research exist?

Promising novel alternatives to acupuncture for peripheral neuropathy include transcutaneous supraorbital nerve stimulation and remote electrical neuromodulation. Both methods have demonstrated efficacy in reducing pain intensity in clinical trials and are non-invasive options for patients.

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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 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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have symptoms of nerve damage from chemotherapy.

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I have a history of nerve damage in my hands or feet.

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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

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

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 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

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

0 / 7Eligibility criteria met

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.