NCT04920097

Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 225 (estimated)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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).

Detailed 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.

Conditions

• Chemotherapy-induced Neuropathy

Interventions

Type	Name	Description
OTHER	In-person training for seed placement and APA	In-person seed placement and a training for the participant or their caregiver to place the seeds on the ear points.
OTHER	Virtual training for seed placement and APA	Self-administer APA by placing the seeds according to the video instruction found in the self-guided smartphone application for understanding and administering APA. Participant and/or a caregiver will follow the video instruction on seed placement.
OTHER	Usual Care	Participants will continue with usual care from oncologist.
OTHER	Post-training zoom session for seed placement and APA coaching	Zoom session for seed placement and APA coaching, to occur after initial APA and seed placement training (initial training is either in person or guided by the smartphone app videos).

Timeline

• Start date: 2021-07-08
• Primary completion: 2025-05-30
• Completion: 2026-05-30
• First posted: 2021-06-09
• Last updated: 2025-12-15

Locations

2 sites across 1 country: United States