Acupuncture Treatment of Chemotherapy-Induced Peripheral Neuropathy in Women With Breast or Gynecologic Cancers: Mechanisms of Action and Feasibility
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- University of Utah
- Enrollment
- 3
- Locations
- 1
- Primary Endpoint
- Number of Participants Who Experience Serious Adverse Events Related to AT Sessions
Study Overview
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 changes in physiological biomarkers when using acupuncture to treat CIPN.
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 will undergo fMRI during the baseline visit, receive 10 sessions of AT, and undergo fMRI after completion of AT. The investigators will examine fMRI for potential neurologic mechanisms of action of AT in CIPN management. The ultimate objective of this pilot project is to lay the foundation for a future randomized controlled clinical trial of AT for CIPN. Specifically, the investigators will be able to demonstrate that the investigators have the team and location in place to conduct a successful trial.
The participant will receive 10 acupuncture treatments over the course of 8 weeks with a baseline fMRI done prior to receiving acupuncture treatments and a final fMRI done after the completion of acupuncture treatments. Participant will receive questionnaires before fMRI, acupuncture treatments following final fMRI and at a 3 month follow up time point. (See below for more detail.)
1.1 Primary Objectives and Endpoints
To evaluate the feasibility to conduct a trial of AT for CIPN + standard of care therapy. Primary feasibility objectives will be evaluated in terms of recruitment (enrollment of 20 women, average of 2 eligible women per month to participate in the trial, identification of appropriate recruitment strategies, the appropriateness of eligibility criteria), retention (70% or more participants comply with 8 or more AT sessions and complete both fMRI scans), safety (zero serious adverse events directly related to AT) and questionnaire completion (70% or more enrolled participants comply with all data collection).
1.1.1 Primary outcome measures: Mean enrollment, completion rate of AT, fMRI, rate of serious adverse events, rate of questionnaire completion.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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 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.
- •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.
Arms & Interventions
Acupuncture Treatment
All participants receive 10 acupuncture treatments over the course of 8 weeks.
Intervention: Acupuncture (Device)
Outcomes
Primary Outcomes
Number of Participants Who Experience Serious Adverse Events Related to AT Sessions
Time Frame: 7 Months
A serious adverse event is any undesirable experience associated with the participation in this study in a participant that results in death, life-threatening conditions, hospitalization, disability or permanent damage or birth defect.
Number of Participants Who Completed Questionnaires
Time Frame: 7 Months
Participants who completed all questionnaires, which were administered at baseline and at 3 months post-treatment.
Mean Monthly Enrollment
Time Frame: 7 Months
We calculated the mean number of participants who enrolled per month while the study was open to accrual.
Number of Participants Compliant With Treatment
Time Frame: 7 Months
Participant retention was defined as the number of participants who attended at least 8 out of 10 AT sessions and completed both fMRI scans
Secondary Outcomes
- Change in Functional Connectivity of Central Pain Networks on fMRI (Z-scores)(9 weeks)
- Change in Participant-reported Symptoms From Before AT to After Study Completion(22 weeks)