Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy

Chemotherapy-induced Neuropathy Clinical Trial

Official title:

Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04920097
• Other study ID #: HSC-SN-21-1085
• Secondary ID: 1R01CA245054-01A
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: August 30, 2025

Study information

• Verified date: April 2024
• Source: The University of Texas Health Science Center, Houston
• Contact: Constance Johnson, PhD, MS, RN
• Phone: 713-500-9936
• Email: Constance.M.Johnson[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: August 30, 2025
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chemotherapy-induced Neuropathy
• Peripheral Nervous System Diseases

Intervention

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.
• 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.
• Usual Care
Participants will continue with usual care from oncologist.
• 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).

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland
United States	The University of Texas Health Science Center at Houston	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	Johns Hopkins University, National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

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* Note: There are 88 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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.	Up to 4 months
Secondary	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
Secondary	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
Secondary	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