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VGAIT for Chemotherapy-induced Peripheral Neuropathy

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Mass General Brigham

Status

Not yet enrolling

Conditions

Chemotherapy-induced Peripheral Neuropathy

Treatments

Other: Video-Guided Acupuncture Imagery Treatment (VGAIT)

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

VGAIT
Experimental group
Treatment:
Other: Video-Guided Acupuncture Imagery Treatment (VGAIT)

Trial contacts and locations

0

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Central trial contact

Jian Kong; Sierra Hodges

Data sourced from clinicaltrials.gov

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