Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy
NCT ID: NCT04920097
Last Updated: 2025-12-15
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
ACTIVE_NOT_RECRUITING
Clinical Phase
NA
Total Enrollment
225 participants
Study Classification
INTERVENTIONAL
Study Start Date
2021-07-08
Study Completion Date
2026-05-30
Brief Summary
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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).
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Detailed Description
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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.
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.
Conditions
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Chemotherapy-induced Neuropathy
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
DOUBLE
Investigators
Outcome Assessors
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.
Study Groups
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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.
Group Type
EXPERIMENTAL
In-person training for seed placement and APA
Intervention Type
OTHER
In-person seed placement and a training for the participant or their caregiver to place the seeds on the ear points.
Post-training zoom session for seed placement and APA coaching
Intervention Type
OTHER
Zoom session for seed placement and APA coaching, to occur after initial APA and seed placement training (initial training is either in person or guided by the smartphone app videos).
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.
Group Type
EXPERIMENTAL
Virtual training for seed placement and APA
Intervention Type
OTHER
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.
Post-training zoom session for seed placement and APA coaching
Intervention Type
OTHER
Zoom session for seed placement and APA coaching, to occur after initial APA and seed placement training (initial training is either in person or guided by the smartphone app videos).
Usual Care Control
Usual Care arm will continue with their usual care.
Group Type
ACTIVE_COMPARATOR
Usual Care
Intervention Type
OTHER
Participants will continue with usual care from oncologist.
Interventions
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In-person training for seed placement and APA
In-person seed placement and a training for the participant or their caregiver to place the seeds on the ear points.
Intervention Type
OTHER
Virtual training for seed placement and APA
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.
Intervention Type
OTHER
Usual Care
Participants will continue with usual care from oncologist.
Intervention Type
OTHER
Post-training zoom session for seed placement and APA coaching
Zoom session for seed placement and APA coaching, to occur after initial APA and seed placement training (initial training is either in person or guided by the smartphone app videos).
Intervention Type
OTHER
Other Intervention Names
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Self-guided smartphone app with video instruction for seed placement and APA
Eligibility Criteria
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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.
* 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
* 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
Minimum Eligible Age
18 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
Sponsor Role
collaborator
Johns Hopkins University
OTHER
Sponsor Role
collaborator
The University of Texas Health Science Center, Houston
OTHER
Sponsor Role
lead
Responsible Party
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Jennifer Kawi
Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN
Role: PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston
Nada Lukkahatai, PHD, MSN, RN
Role: PRINCIPAL_INVESTIGATOR
Johns Hopkins University
Locations
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Johns Hopkins University
Baltimore, Maryland, United States
Site Status
The University of Texas Health Science Center at Houston
Houston, Texas, United States
Site Status
Countries
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United States
References
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Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
HSC-SN-21-1085
Identifier Type: -
Identifier Source: org_study_id
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