Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy (NCT04920097) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy
United States225 participantsStarted 2021-07-08
Plain-language 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).
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pain severity as assessed by the Brief Pain Inventory
Timeframe: Up to 4 months
2
Change in numbness as assessed by the Brief Pain Inventory
Timeframe: Up to 4 months
3
Change in tingling as assessed by the Brief Pain Inventory
Timeframe: Up to 4 months
4
Change in physical function as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29
Timeframe: Up to 4 months
Trial details
NCT IDNCT04920097
SponsorThe University of Texas Health Science Center, Houston