Auricular Point Acupressure to Manage Chemotherapy Induced Neuropathy

NCT04920097 | Active Not Recruiting DMC

• 2 other identifiers: HSC-SN-21-10851R01CA245054-01A1
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Chemotherapy-induced Neuropathy

Keywords

acupressure; chemotherapy induced neuropathy; auricular acupressure

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (4)

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

  Up to 4 months

• Change of brain activity as assessed by fMRI Neuroimaging

  Up to 1 month

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

  Up to 4 months

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

  Up to 4 months

Study Arms (3)

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.

Other: In-person training for seed placement and APA; Other: Post-training zoom session for seed placement and APA coaching

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.

Other: Virtual training for seed placement and APA; Other: Post-training zoom session for seed placement and APA coaching

Usual Care Control

ACTIVE COMPARATOR

Usual Care arm will continue with their usual care.

Other: Usual Care

Interventions

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.

Auricular Point Acupressure (APA)

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.

Also known as: Self-guided smartphone app with video instruction for seed placement and APA

Virtual Auricular Point Acupressure (vAPA)

Usual Care OTHER

Participants will continue with usual care from oncologist.

Usual Care Control

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).

Auricular Point Acupressure (APA); Virtual Auricular Point Acupressure (vAPA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Cancer Institute (NCI): collaborator
• Johns Hopkins University: collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

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MeSH Terms

Interventions

Glutamyl Aminopeptidase

Intervention Hierarchy (Ancestors)

Aminopeptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloexopeptidases; Metalloproteases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 3, 2021
• First Posted: June 9, 2021
• Study Start: July 8, 2021
• Primary Completion: May 30, 2025
• Study Completion (Estimated): May 30, 2026
• Last Updated: December 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)