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Acupuncture Therapy for the Treatment of Chemotherapy-Induced Peripheral Neuropathy in Patients with Breast or Gynecologic Cancer

Trial Status: Active

This phase II trial studies how well acupuncture therapy works in treating chemotherapy-induced peripheral neuropathy in patients with breast or gynecologic cancer. Peripheral neuropathy is a disorder of the longest nerves in the body that results in symptoms of numbness, tingling and sometimes pain that begins at the toes and may spread up the legs, causing problems with balance, weakness, and pain. Chemotherapy-induced peripheral neuropathy is one of the most common complications of many commonly used chemotherapy drugs and is a frequent cause for the dose of these drugs to be lowered, or for them to be discontinued. Acupuncture treatment is a well-tolerated and safe treatment option frequently used for symptoms associated with cancer therapies including chemotherapy-induced peripheral neuropathy. This trial may help researchers learn how well acupuncture works for treating chemotherapy-induced peripheral neuropathy.

Inclusion Criteria

  • Histologically proven breast, uterine, cervical or ovarian cancer of any stage
  • Received either a paclitaxel treatment dose of at least 480 mg/m^2 paclitaxel as a single or combination agent or a docetaxel treatment dose of at least 150 mg/m^2 docetaxel as a single or combination agent. Treatment must be completed at least 3 months prior to enrollment
  • Eligible patients report at least 1 month of altered sensation and/or pain in the feet (with or without presence in one or both hands) with a score of greater than or equal to 20 for CIPN on the sensory subscale of the CIPN-20 (scale 0-100)
  • Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines
  • Eastern Cooperative Oncology Group (ECOG) status of 0 (asymptomatic), 1 (symptomatic but completely ambulatory) or 2 (symptomatic, < 50% in bed during the day)

Exclusion Criteria

  • Preexisting neuropathy due to other identified etiologies includes diabetes, vitamin B12 deficiency, or alcoholism
  • Having received more than 6 acupuncture treatments for any condition in the last six months
  • Patients with claustrophobia, pacemakers, non-magnetic resonance imaging (MRI) compatible breast expanders or port-a-caths, neurostimulator devices, current or expected pregnancy, exposure to shrapnel, left-handedness, recent tattoos or otherwise unsafe for MRI scanning

Utah

Salt Lake City
Huntsman Cancer Institute / University of Utah
Status: ACTIVE
Contact: Lisa Taylor-Swanson
Phone: 801-585-5486

PRIMARY OBJECTIVE:

I. To evaluate the feasibility to conduct a trial of acupuncture treatment (AT) for chemotherapy-induced peripheral neuropathy (CIPN) + standard of care therapy.

SECONDARY OBJECTIVES:

I. To evaluate the impact of AT on the reported experience of CIPN.

II. To evaluate central pain processing and cortical connectivity in patients with CIPN treated by acupuncture by analyzing functional magnetic resonance imaging (fMRI) of all participants.

III. To evaluate if there is any change in patient-reported measures from before AT to after study completion.

OUTLINE:

Patients undergo acupuncture treatment over 45-60 minutes twice weekly for 2 weeks and then once weekly for 6 weeks for a total of 10 treatments over 2 months. Patients also undergo fMRI at baseline and within one week of final acupuncture treatment.

Trial Phase Phase II

Trial Type Supportive care

Lead Organization
Huntsman Cancer Institute / University of Utah

Principal Investigator
Lisa Taylor-Swanson

  • Primary ID HCI107709
  • Secondary IDs NCI-2020-03999
  • Clinicaltrials.gov ID NCT04067544