Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 80 Years
Eligible Sex
Female
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Intervention Model Description
Video-Guided Acupuncture Imagery Treatment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
VGAIT
  • 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

Recruiting Locations

Massachusetts General Hospital
Charlestown 4932819, Massachusetts 6254926 02129
Contact:
Sierra Hodges, B.S.
617-726-5004
sahodges@mgb.org

More Details

Status
Recruiting
Sponsor
Massachusetts General Hospital

Study Contact

Sierra Hodges
6177265004
sahodges@mgb.org

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.