Clinical trial NCT04920097: Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy
Official title: Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Chemotherapy-induced Neuropathy
Keywords: acupressure
chemotherapy induced neuropathy
auricular acupressure
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Johns Hopkins University
First posted: 2021-06-09
Enrollment: 225
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in pain severity as assessed by the Brief Pain Inventory
timeFrame: Up to 4 months
measure: Change in numbness as assessed by the Brief Pain Inventory
timeFrame: Up to 4 months
measure: Change in tingling as assessed by the Brief Pain Inventory
timeFrame: Up to 4 months
measure: Change in physical function as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29
timeFrame: Up to 4 months
Secondary outcomes:
measure: Change of pain sensitivity as assessed by Qualitative Sensory Testing (QST)
timeFrame: Up to 4 months
measure: Change of brain activity as assessed by fMRI Neuroimaging
timeFrame: Up to 1 month
measure: Change in anti-inflammatory cytokines as assessed by serum cytokine biomarkers
timeFrame: Up to 4 months
measure: Change in pro-inflammatory cytokines as assessed by serum cytokine biomarkers
timeFrame: Up to 4 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Constance Johnson, PhD, MS, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Johns Hopkins University
name: Nada Lukkahatai, PHD, MSN, RN
role: PRINCIPAL_INVESTIGATOR
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