VGAIT for Chemotherapy-induced Peripheral Neuropathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Video-Guided Acupuncture Imagery Treatment (VGAIT).
- Who it may be relevant to
- Registry conditions: Chemotherapy-induced Peripheral Neuropathy. Basic parameters: 18 years — 80 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Video-Guided Acupuncture Imagery Treatment in Chemotherapy-induced Peripheral Neuropathy
Overview
Perform a feasibility study on imagined acupuncture treatment of Chemotherapy-induced peripheral neuropathy (CIPN)
Detailed description
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.
Interventions
- Other 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
Primary outcome measures
- Feasibility related outcomes [Time frame: 8 week]
Secondary outcome measures (6)
- Patient Neurotoxicity Questionnaire (PNQ) [Time frame: baseline, 8 week]
- Functional Assessment of Cancer Therapy-Neurotoxicity subscale (FACT-NTX) [Time frame: baseline, 8 week]
- Brief Pain Inventory-short form (BPI-SF) [Time frame: baseline, 8 week]
- European Organisation for Research and Treatment of Cancer Quality-of-Life Questionnaire Core 30 (QLQ-C30) instrument [Time frame: baseline, 8 week]
- MGH Acupuncture Sensation Scale (MASS) [Time frame: after each intervention]
- Pain Catastrophizing Scale (PCS) [Time frame: baseline, 8 week]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Massachusetts General Hospital — Charlestown
Identifiers
NCT: NCT07177820 · 25-307