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NCT Number: NCT04920097

Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy

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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Key information

Conditions

Chemotherapy-induced Neuropathy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Johns Hopkins University, Baltimore, Maryland, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

In-person training for seed placement and APA

Other

In-person seed placement and a training for the participant or their caregiver to place the seeds on the ear points.

Virtual training for seed placement and APA

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.

Other names: Self-guided smartphone app with video instruction for seed placement and APA

Usual Care

Other

Participants will continue with usual care from oncologist.

Post-training zoom session for seed placement and APA coaching

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).

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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

  1. Change of pain sensitivity as assessed by Qualitative Sensory Testing (QST)

    Time frame: Up to 4 months

    Pain sensitivity will be measured by QST. The QST battery consists of light touch sensation as assessed by the Semmes-Weinstein Monofilament Test (SWMT), threshold and tolerance, temporal summation, and conditioned pain modulation (CPM). The threshold responses will be conducted in randomized and counterbalanced order; CPM will always occur last. Temporal summation measures, CPM, and after-sensation responses to these measures will be combined to create the central sensitization index for use in statistical analyses.

  2. Change of brain activity as assessed by fMRI Neuroimaging

    Time frame: Up to 1 month

    All Functional magnetic resonance imaging (fMRIs) will be acquired on a 3.0 Tesla Siemens Prisma System (Siemens Medical Solutions, Erlangen, Germany) at The Johns Hopkins Hospital Radiology Building, Baltimore. Blood Oxygen Level Dependent functional images will be acquired using 2D gradient echo echo-planar imaging to cover the whole head [repetition time (TR)=2000ms, echo time (TE)=30ms, flip angle 90 degrees, acquisition matrix 64x64x40, slice thickness 4mm]; 300 volumes will be acquired for each fMRI data point. All imaging systems are connected to the hospital picture archiving and communication system. Each scan will take approximately 20 minutes.

    The investigator will report the functional connectivity networks of the Pearson correlation coefficient which ranges from 0 (no correlation) to 100 (perfect correlation).

  3. Change in anti-inflammatory cytokines as assessed by serum cytokine biomarkers

    Time frame: Up to 4 months

    A 15-mL blood sample will be drawn at each time point and blood samples will be collected using standard phlebotomy procedures and will be transferred and processed at the Johns Hopkins School of Nursing (JHSON) basic science laboratory (coagulation and serum separation by centrifugation). Serum will be stored at -80 °C at the JHSON. Once the study collection is completed, a panel of cytokines will be measured in diluted samples using the bio-plex pro-human chemokine panel.

    The investigator will report the number of participants that have a change in any anti-inflammatory cytokines level greater than 50 percent of baseline

  4. Change in pro-inflammatory cytokines as assessed by serum cytokine biomarkers

    Time frame: Up to 4 months

    A 15-mL blood sample will be drawn at each time point and blood samples will be collected using standard phlebotomy procedures and will be transferred and processed at the Johns Hopkins School of Nursing (JHSON) basic science laboratory (coagulation and serum separation by centrifugation). Serum will be stored at -80 °C at the JHSON. Once the study collection is completed, a panel of cytokines will be measured in diluted samples using the bio-plex pro-human chemokine panel.

    The investigator will report the number of participants that have a change in any pro-inflammatory cytokine level greater than 50 percent of baseline

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Johns Hopkins University
  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2021
Primary completion
2025
Study completion
2026
First posted
Jun 9, 2021
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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