Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy

The University of Texas System (UT)

Status: Active, not recruiting

Conditions: Chemotherapy-induced Neuropathy

Treatments: Other: Usual Care; Other: Virtual training for seed placement and APA; Other: In-person training for seed placement and APA; Other: Post-training zoom session for seed placement and APA coaching

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04920097

HSC-SN-21-1085

1R01CA245054-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 225 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• cancer patients ages ≥18 years
• have received a medication in one of the following categories: platinum-based, vinca alkaloids, bortezomib, eribulin, and/or taxanes
• have CIN due to receiving neurotoxic chemotherapy for cancer or have pre-existing peripheral neuropathy of another etiology that worsened after chemotherapy
• have one of the average intensity of pain, or numbness, or tingling on their extremities the previous week due to CIN ≥ 4 on a 11-point numerical scale.

Exclusion criteria

• use of an investigational agent for pain control concurrently or within the past 30 days
• use of an implantable drug delivery system, e.g. Medtronic SynchroMed®
• prior celiac plexus block or other neurolytic pain control treatment
• other identified causes of painful paresthesia existing prior to chemotherapy (e.g., radiation or malignant plexopathy, lumbar or cervical radiculopathy,)
• allergy to latex (the tapes for the APA include latex) and/or having a history of allergic reactions to the adhesive tape
• pregnant women (based on the self-reported data)
• individuals diagnosed with diabetic neuropathy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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225 participants in 3 patient groups

Auricular Point Acupressure (APA)

Experimental group

Description:

The APA arm will receive in-person weekly treatments and a self-guided smartphone application with videos for understanding and administering APA. The APA arm will receive one in-person seed placement and a training for the participant or their caregiver to place the seeds on the ear points, as well as one zoom meeting 1 week after the first visit to coach participant and/or caregiver on seed placement.

Treatment:

Other: Post-training zoom session for seed placement and APA coaching

Other: In-person training for seed placement and APA

Virtual Auricular Point Acupressure (vAPA)

Experimental group

Description:

The vAPA arm will 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 and will receive one zoom session for APA coaching one week after the baseline visit.

Treatment:

Other: Post-training zoom session for seed placement and APA coaching

Other: Virtual training for seed placement and APA

Usual Care Control

Active Comparator group

Description:

Usual Care arm will continue with their usual care.

Treatment:

Other: Usual Care