Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy

April 4, 2024 updated by: Constance Johnson, The University of Texas Health Science Center, Houston
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

225

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Recruiting
        • Johns Hopkins University
        • Contact:
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • The University of Texas Health Science Center at Houston
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
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).
Experimental: 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.
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).
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.
Other Names:
  • Self-guided smartphone app with video instruction for seed placement and APA
Active Comparator: Usual Care Control
Usual Care arm will continue with their usual care.
Other: Usual Care
Participants will continue with usual care from oncologist.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Up to 4 months
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).
Up to 4 months
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).
Up to 4 months
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).
Up to 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 4 months
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).
Up to 1 month
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
Up to 4 months
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
Up to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

Johns Hopkins University
National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Constance Johnson, PhD, MS, RN, The University of Texas Health Science Center, Houston
  • Principal Investigator: Nada Lukkahatai, PhD, MSN, RN, Johns Hopkins University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2021

Primary Completion (Estimated)

August 30, 2024

Study Completion (Estimated)

August 30, 2025

Study Registration Dates

First Submitted

June 3, 2021

First Submitted That Met QC Criteria

June 3, 2021

First Posted (Actual)

June 9, 2021

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSC-SN-21-1085
  • 1R01CA245054-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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