VGAIT for Chemotherapy-induced Peripheral Neuropathy

Massachusetts General Hospital20 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chemotherapy-induced Peripheral Neuropathy

Interventions

Video-Guided Acupuncture Imagery Treatment (VGAIT)OTHER

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

Massachusetts General Hospital

Charlestown, Massachusetts, United States

RECRUITING

Outcomes

Primary Outcomes

Feasibility related outcomes

Completion, satisfaction

Time frame: 8 week

Secondary Outcomes

Patient Neurotoxicity Questionnaire (PNQ)

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

Time frame: baseline, 8 week

Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX)

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

Time frame: baseline, 8 week

Brief Pain Inventory-short form (BPI-SF)

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

Time frame: baseline, 8 week

European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (QLQ-C30) instrument

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

Time frame: baseline, 8 week

MGH Acupuncture Sensation Scale (MASS)

scale includes 12 descriptors of sensations frequently described during acupuncture treatment

Time frame: after each intervention

Pain Catastrophizing Scale (PCS)

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

Time frame: baseline, 8 week

Central Contacts

Sierra Hodges

CONTACT

6177265004 sahodges@mgb.org

Jian Kong

CONTACT

16179620978 jkong2@mgh.harvard.edu

Data from ClinicalTrials.gov

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