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Video-Guided Acupuncture Imagery for Chemotherapy-induced Peripheral Neuropathy in Breast Cancer

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What is being tested

Video-Guided Acupuncture Imagery Treatment (VGAIT)

Other
Who is being recruted

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: November 2025
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Study ContactSierra HodgesMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: November 1, 2025Actual date on which the first participant was enrolled.

The study aims to explore a new approach called Video-Guided Acupuncture Imagery Treatment (VGAIT) to help people with breast cancer who have ongoing problems with nerve pain or numbness after chemotherapy, known as chemotherapy-induced peripheral neuropathy (CIPN). This condition often affects patients' quality of life, and finding effective ways to manage it is important. The study targets individuals with stage I-III breast cancer who continue to experience these symptoms despite completing their chemotherapy. By investigating VGAIT, the study hopes to offer a potential new method to alleviate the discomfort associated with CIPN. Participants in the study will undergo 16 sessions of VGAIT over a period of 8 weeks, conducted remotely via Zoom. The treatment involves guided imagery, which is a technique that uses visualization to help manage pain and discomfort. Researchers will evaluate how well participants continue with the treatment, how satisfied they are with this new method, and whether they complete all the study assessments. These factors will help determine the feasibility of using VGAIT for managing CIPN. The study measures are taken at the beginning, halfway through, and at the end of the 8-week period to assess the progress and effectiveness of the treatment.

Official TitleVideo-Guided Acupuncture Imagery Treatment in Chemotherapy-induced Peripheral Neuropathy 
NCT07177820
Principal SponsorMassachusetts General Hospital
Study ContactSierra HodgesMore contacts
Last updated: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
20 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria
FemaleBiological sex of participants that are eligible to enroll.
From 18 to 80 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Criteria

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.

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental

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

Completion, satisfaction
Secondary Objectives

a widely used, validated instrument that assesses the impact of neuropathy on health-related quality of life

A tool designed to assess neurotoxic effects in patients who have undergone treatments such as chemotherapy

An instrument used to evaluate the severity of pain, including neuropathic pain, and the impact on the patient's daily functioning.

an instrument developed to assess the quality of life in cancer patients

scale includes 12 descriptors of sensations frequently described during acupuncture treatment

a 13-item self-report scale which measures pain-related rumination, magnification, and helplessness

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
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