Status:
TERMINATED
Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women
Lead Sponsor:
University of Utah
Conditions:
Chemotherapy-induced Peripheral Neuropathy
Breast Cancer Female
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This pilot study aims to evaluate the feasibility to conduct a study of acupuncture treatment (AT) for Chemotherapy-Induced Peripheral Neuropathy (CIPN) at Huntsman Cancer Institute and to investigate...
Detailed Description
This pilot feasibility study aims to determine if conducting a trial of AT for CIPN is feasible at Huntsman Cancer Institute (HCI). The investigators aim to enroll and retain twenty participants who w...
Eligibility Criteria
Inclusion
- Female age 18 or older.
- Histologically proven breast, uterine, cervical or ovarian cancer of any stage.
- Received either (1) a Paclitaxel treatment dose of at least 480 mg/m2 paclitaxel as a single or combination agent or (2) a Docetaxel treatment dose of at least 150 mg/m2 docetaxel as a single or combination agent. Treatment must be completed at least 3 months prior to enrollment.
- Eligible participants 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
- 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.
- Participants with claustrophobia, pacemakers, non-MRI compatible breast expanders or port-a-caths, neurostimulator devices, current pregnancy, exposure to shrapnel, left-handedness, or otherwise unsafe for MRI scanning.
Key Trial Info
Start Date :
November 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 12 2020
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT04067544
Start Date
November 5 2019
End Date
August 12 2020
Last Update
April 6 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Huntsman Cancer Institute
Salt Lake City, Utah, United States, 84112