Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy
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- STATUS
- Recruiting
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- End date
- Aug 30, 2024
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- participants needed
- 240
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- sponsor
- Johns Hopkins University
Summary
The proposed randomized control trial will evaluate auricular point acupressure (APA) on chemotherapy-induced neuropathy (CIN), rigorously considering point specificity and placebo effects by integrating self-report measures, psychophysical measures (QST), endogenous biomarkers (cytokines), and neuro-imaging to investigate APA's efficacy and underlying mechanism(s).
The investigators will use a randomized control trial, three-group design: (1) APA Group, (2) Sham APA Control, and (3) Usual Care Control. A smartphone application for ecological momentary assessment (EMA) will be used to monitor APA adherence and capture momentary CIN severity and analgesic use.
Description
Chemotherapy-induced neuropathy (CIN)-pain, numbness, or tingling distributed in the hands and feet-produces persistent symptoms affecting sensation and balance in cancer survivors. Up to 50% of cancer survivors still suffer CIN 6 years after treatment. Duloxetine, the only recommended drug by the American Society of Clinical Oncology, was found to be superior to placebo but improved CIN by only 0.73 points (0-10 scale). No effective treatment for CIN has been established except exercise, with an effect size of <0.508. Opioids relieve CIN pain, but long-term use is strongly discouraged due to opioid overuse.
The investigators propose to test auricular point acupressure (APA), an innovative and scalable solution developed from auricular acupuncture. APA is a non-invasive (needleless) and active treatment for patients with pain, whereas acupuncture is an invasive (using needles) and passive treatment (administered by a licensed practitioner). In APA, small seeds are taped on specific ear points by a skilled provider and patients press on the seeds to stimulate ear points three times daily, three minutes per time, for a total of nine minutes per day. APA provides pain relief within 1-2 minutes after ear stimulation and sustains pain relief for one month after a 4-week APA intervention. APA is popular in Taiwan, China, and Europe. Though its use is sparse in the U.S., a limited number of clinical trials have supported APA in pain management.
Details
| Condition | Chemotherapy-induced Neuropathy |
|---|---|
| Treatment | Usual Care, Virtual Auricular Point Acupressure (APA), In-Person Training |
| Clinical Study Identifier | NCT04920097 |
| Sponsor | Johns Hopkins University |
| Last Modified on | 12 November 2021 |
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