Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chemotherapy-induced Neuropathy
- Sponsor
- The University of Texas Health Science Center, Houston
- Enrollment
- 225
- Locations
- 2
- Primary Endpoint
- Change in numbness as assessed by the Brief Pain Inventory
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
Brief 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.
Investigators
Jennifer Kawi
Professor
The University of Texas Health Science Center, Houston
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in numbness as assessed by the Brief Pain Inventory
Time Frame: Up to 4 months
Numbness will be assessed using the revised Brief Pain Inventory (BPI). The scale ranges from 0 (no numbness) to 10 (severe numbness).
Change in pain severity as assessed by the Brief Pain Inventory
Time Frame: Up to 4 months
Pain severity will be assessed using the revised Brief Pain Inventory (BPI). The scale ranges from 0 (no pain) to 10 (severe pain).
Change in tingling as assessed by the Brief Pain Inventory
Time Frame: Up to 4 months
Tingling will be assessed using the revised Brief Pain Inventory (BPI). The scale ranges from 0 (no tingling) to 10 (severe tingling).
Change in physical function as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29
Time Frame: Up to 4 months
Physical function will be assessed using the subscale of physical function, Patient-Reported Outcomes Measurement Information System (PROMIS) 29. The subscale of physical function has a range of 5 (unable to function) to 20 (able to function without difficulty).
Secondary Outcomes
- Change of pain sensitivity as assessed by Qualitative Sensory Testing (QST)(Up to 4 months)
- Change of brain activity as assessed by fMRI Neuroimaging(Up to 1 month)
- Change in anti-inflammatory cytokines as assessed by serum cytokine biomarkers(Up to 4 months)
- Change in pro-inflammatory cytokines as assessed by serum cytokine biomarkers(Up to 4 months)