VGAIT for Chemotherapy-induced Peripheral Neuropathy

NCT ID: NCT07177820

Last Updated: 2025-09-17

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-11-01

Study Completion Date

2026-12-31

Brief Summary

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Perform a feasibility study on imagined acupuncture treatment of Chemotherapy-induced peripheral neuropathy (CIPN)

Detailed Description

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We will perform a pilot study to assess the feasibility of Video-Guided Acupuncture Imagery Treatment (VGAIT) on CIPN symptoms in patients with stage I-III breast cancer with persistent CIPN after adjuvant chemotherapy. Participants will receive 16 sessions of VGAIT over 8 weeks remotely through the zoom. Study measures will be collected at the time of study enrollment, week 4, and week 8. The primary endpoints of the study will be 1) retention to treatment; 2) satisfaction for the intervention and 3) completion of study assessments.

Conditions

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Chemotherapy-induced Peripheral Neuropathy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Video-Guided Acupuncture Imagery Treatment
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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VGAIT

Group Type EXPERIMENTAL

Video-Guided Acupuncture Imagery Treatment (VGAIT)

Intervention Type OTHER

Participants watch a video of acupuncture being applied to the body while simultaneously imagining that it is being administered to them

Interventions

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Video-Guided Acupuncture Imagery Treatment (VGAIT)

Participants watch a video of acupuncture being applied to the body while simultaneously imagining that it is being administered to them

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* at least 18 years of age
* have histologically confirmed stage I-III breast cancer,
* have completed adjuvant taxane-based chemotherapy (alone or in combination), ,
* have an Eastern Cooperative Oncology Group performance status of 0 or 1, and reported grade 1 or greater CIPN symptoms for more than 2 weeks as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 4.03.

Exclusion Criteria

* concurrent chemotherapy (there were no limitations on time from the last paclitaxel administration),
* having metastatic or recurrent disease,
* history of preexisting peripheral neuropathy prior to chemotherapy,
* uncontrolled seizure disorder,
* unstable cardiac disease or myocardial infarction within 6 months prior to study entry, being pregnant or nursing, or having used acupuncture for CIPN within 6 months prior to study entry.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian Kong

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Sierra Hodges

Role: CONTACT

6177265004

Jian Kong

Role: CONTACT

16179620978

Other Identifiers

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25-307

Identifier Type: -

Identifier Source: org_study_id

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