Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy

Last updated: December 5, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Neuropathy

Effects Of Chemotherapy

Neurologic Disorders

Treatment

Virtual training for seed placement and APA

Post-training zoom session for seed placement and APA coaching

In-person training for seed placement and APA

Clinical Study ID

NCT04920097
HSC-SN-21-1085
1R01CA245054-01A1
  • Ages > 18
  • All Genders
  • Accepts Healthy Volunteers

Study 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).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • cancer patients ages ≥18 years

  • have received a medication in one of the following categories: platinum-based, vincaalkaloids, bortezomib, eribulin, and/or taxanes

  • have CIN due to receiving neurotoxic chemotherapy for cancer or have pre-existingperipheral neuropathy of another etiology that worsened after chemotherapy

  • have one of the average intensity of pain, or numbness, or tingling on theirextremities the previous week due to CIN ≥ 4 on a 11-point numerical scale.

Exclusion

Exclusion Criteria:

  • use of an investigational agent for pain control concurrently or within the past 30days

  • 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 ofallergic reactions to the adhesive tape

  • pregnant women (based on the self-reported data)

  • individuals diagnosed with diabetic neuropathy

Study Design

Total Participants: 225
Treatment Group(s): 6
Primary Treatment: Virtual training for seed placement and APA
Phase:
Study Start date:
July 08, 2021
Estimated Completion Date:
August 30, 2025

Study 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.

Connect with a study center

  • Johns Hopkins School of Nursing

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Johns Hopkins University

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • The University of Texas Health Science Center at Houston

    Houston, Texas 77030
    United States

    Site Not Available

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