Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy

  • STATUS
    Recruiting
  • End date
    Aug 30, 2024
  • participants needed
    240
  • sponsor
    Johns Hopkins University
Updated on 12 November 2021
Accepts healthy volunteers

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 IdentifierNCT04920097
SponsorJohns Hopkins University
Last Modified on12 November 2021

Eligibility

Yes No Not Sure

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 completed their course of chemotherapy three months or more before enrollment
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)
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