Acupuncture for Persistent Chemotherapy-induced Peripheral Neuropathy Symptoms in Solid Tumor Survivors: A Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 75
- Locations
- 2
- Primary Endpoint
- change in the proportion of patients with a CIPN severity
Study Overview
Brief Summary
The purpose of this study is to compare the effects of real acupuncture with placebo acupuncture or usual care on symptoms of nerve damage from chemotherapy.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •English-speaking
- •Age ≥ 18 years old
- •Solid tumor survivors with no evidence of disease
- •Moderate to severe CIPN, defined by symptoms such as numbness, tingling, or pain ratings of 4 or greater on a 0-10 numeric rating scale (NRS)
- •Have completed neurotoxic chemotherapy at least 3 months prior to enrollment
- •If taking anti-neuropathy medications, they are on a stable regimen (no change in 3 months)
Exclusion Criteria
- •Patients with a pacemaker
- •Prior acupuncture treatment within 5 years of enrollment
Arms & Interventions
Acupuncture Treatment Group
Ten acupuncture treatments over the course of eight weeks, with twice weekly acupuncture treatments for the first two weeks, and then weekly treatment thereafter.
Intervention: Acupuncture (Procedure)
Acupuncture Treatment Group
Ten acupuncture treatments over the course of eight weeks, with twice weekly acupuncture treatments for the first two weeks, and then weekly treatment thereafter.
Intervention: questionnaires (Behavioral)
Sham Acupuncture Treatment Group
Ten sham acupuncture treatments over the course of eight weeks, with twice weekly sham acupuncture treatments for the first two weeks, and then weekly sham acupuncture treatment thereafter.
Intervention: Sham Acupuncture (Procedure)
Sham Acupuncture Treatment Group
Ten sham acupuncture treatments over the course of eight weeks, with twice weekly sham acupuncture treatments for the first two weeks, and then weekly sham acupuncture treatment thereafter.
Intervention: questionnaires (Behavioral)
Usual Care Group
Twelve weeks of usual care.
Intervention: Usual Care Group (Other)
Usual Care Group
Twelve weeks of usual care.
Intervention: questionnaires (Behavioral)
Outcomes
Primary Outcomes
change in the proportion of patients with a CIPN severity
Time Frame: up to 12 weeks
according to the NCI-CTC 4.0
Secondary Outcomes
No secondary outcomes reported