The Effect of Acupuncture on Nerve Pain Caused by Taxane (Chemotherapy) Treatment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-11

Study Completion Date

2026-07-31

Brief Summary

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Some people experience a side effect while they are receiving taxane called taxane-induced peripheral neuropathy (TIPN). TIPN is pain in the arms and legs due to nerve damage caused by cancer treatment and may interfere with quality of life. The purpose of this study is to learn if acupuncture can prevent TIPN from getting worse. Acupuncture is a medical technique that involves insertion of very thin needles into specific areas on the body. We will compare real acupuncture (RA) to placebo (sham) acupuncture (SA). SA is done like RA, but will use different needles and target different sites or places on the body than RA. We are comparing RA to SA to learn whether RA can prevent TIPN from getting worse while receiving taxane.

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Detailed Description

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The study will include two phases. The first phase is the screening phase, in which patients with early stage breast cancer undergoing taxane therapy will consent and receive TIPN screening each week till they develop grade 1 or higher by CTCAE criteria. The patients with TIPN grade 1 or higher will then be consented to the intervention phase, in which patients will be randomized to receive either weekly real or sham acupuncture treatment using a standardized, semi-fixed protocol developed in our preliminary studies to improve TIPN pain. The participant may also participate in Part 2 of the study if they begin to experience TIPN but do not participate in Part 1.

Conditions

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Breast Cancer Taxane-Induced Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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real acupuncture (RA)

Real Acupuncture weekly till taxane completion

Group Type ACTIVE_COMPARATOR

Real Acupuncture

Intervention Type PROCEDURE

Real Acupuncture weekly till taxane completion

sham acupuncture (SA)

Sham Acupuncture weekly till taxane completion

Group Type PLACEBO_COMPARATOR

Sham Acupuncture

Intervention Type OTHER

Sham Acupuncture weekly till taxane completion

Interventions

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Real Acupuncture

Real Acupuncture weekly till taxane completion

Intervention Type PROCEDURE

Sham Acupuncture

Sham Acupuncture weekly till taxane completion

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Screening Phase:

* English or Spanish-proficient men and women aged ≥18 years
* Histological diagnoses of invasive carcinoma of the breast
* Plan to receive curative intent chemotherapy regimen containing 12 weeks weekly paclitaxel or nab-paclitaxel as standard of care

Intervention Phase:

* TIPN grade ≥1 based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, developed while receiving taxane
* ≥ 4 4 weeks of either weekly paclitaxel or nab-paclitaxel, or paclitaxel or abraxane with dosing every 2-3 weeks planned, as standard of care and at treating physician's discretion
* Willing to adhere to requirement that no new pain medication or dose changes be taken throughout the first 12 weeks of the study period
* Willing to adhere to all study-related procedures, including randomization to one of the two possible acupuncture treatments

Exclusion Criteria

Screening Phase:

* Pre-existing peripheral neuropathy within 28 days of screening consent
* Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine

Intervention Phase:

* Currently taking anti-neuropathy medication such as gabapentin, pregabalin, duloxetine or glutamine
* Use of acupuncture for symptom management within 28 days of intervention consent

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No