Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy
Purpose
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).
Condition
- Chemotherapy-induced Neuropathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- Yes
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
- Masking Description
- Participants and interventionists cannot be masked to the three arms. The PI and Co-Is will be blinded regarding arm assignment and will not contact or interact with the participants during the intervention and outcome assessments. Data collector for outcome assessments will be blinded since there will be no seeds placed on the ears when the data are collected.
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Auricular Point Acupressure (APA) |
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. |
|
|
Experimental Virtual Auricular Point Acupressure (vAPA) |
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. |
|
|
Active Comparator Usual Care Control |
Usual Care arm will continue with their usual care. |
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Recruiting Locations
Houston, Texas 77030
More Details
- Status
- Recruiting
- Sponsor
- The University of Texas Health Science Center, Houston
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.