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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA245054-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Johns Hopkins University | OTHER |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Auricular Point Acupressure (APA) | Experimental | 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. |
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| Virtual Auricular Point Acupressure (vAPA) | Experimental | 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. |
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| Usual Care Control | Active Comparator | Usual Care arm will continue with their usual care. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in pain severity as assessed by the Brief Pain Inventory | Pain severity will be assessed using the revised Brief Pain Inventory (BPI). The scale ranges from 0 (no pain) to 10 (severe pain). | Up to 4 months |
| Change in numbness as assessed by the Brief Pain Inventory | Numbness will be assessed using the revised Brief Pain Inventory (BPI). The scale ranges from 0 (no numbness) to 10 (severe numbness). | Up to 4 months |
| Change in tingling as assessed by the Brief Pain Inventory | Tingling will be assessed using the revised Brief Pain Inventory (BPI). The scale ranges from 0 (no tingling) to 10 (severe tingling). | Up to 4 months |
| Change in physical function as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29 | 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). | Up to 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change of pain sensitivity as assessed by Qualitative Sensory Testing (QST) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Kawi, PhD, MSN, FNP-BC, CNE, FAAN | The University of Texas Health Science Center, Houston | Principal Investigator |
| Nada Lukkahatai, PHD, MSN, RN | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21205 | United States | ||
| The University of Texas Health Science Center at Houston |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29439162 | Background | Shah A, Hoffman EM, Mauermann ML, Loprinzi CL, Windebank AJ, Klein CJ, Staff NP. Incidence and disease burden of chemotherapy-induced peripheral neuropathy in a population-based cohort. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):636-641. doi: 10.1136/jnnp-2017-317215. Epub 2018 Feb 8. | |
| 29463571 | Background | Park SB. Chemotherapy-induced peripheral neuropathy: highlighting unmet needs. J Neurol Neurosurg Psychiatry. 2018 Jun;89(6):558. doi: 10.1136/jnnp-2017-317528. Epub 2018 Feb 20. No abstract available. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 26, 2026 | |
| Reset | Jun 22, 2026 |
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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.
| 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. |
|
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| Usual Care | Other | Participants will continue with usual care from oncologist. |
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| 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). |
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| Up to 4 months |
| Change of brain activity as assessed by fMRI Neuroimaging | 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). | Up to 1 month |
| Change in anti-inflammatory cytokines as assessed by serum cytokine biomarkers | 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 | Up to 4 months |
| Change in pro-inflammatory cytokines as assessed by serum cytokine biomarkers | 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 | Up to 4 months |
| Houston |
| Texas |
| 77030 |
| United States |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 26, 2026 | Jun 22, 2026 | |||
| Jul 9, 2026 |
| ID | Term |
|---|---|
| D043384 | Glutamyl Aminopeptidase |
| ID | Term |
|---|---|
| D000626 | Aminopeptidases |
| D020689 | Exopeptidases |
| D010447 | Peptide Hydrolases |
| D006867 | Hydrolases |
| D004798 | Enzymes |
| D045762 | Enzymes and Coenzymes |
| D045727 | Metalloexopeptidases |
| D045726 | Metalloproteases |
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