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Acupressure for Peripheral Neuropathy

N/A

Recruiting

Led By Nada Lukkahatai, PHD, MSN, RN

Research Sponsored by The University of Texas Health Science Center, Houston

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Have received a medication in one of the following categories: platinum-based, vinca alkaloids, bortezomib, eribulin, and/or taxanes

Have completed their course of chemotherapy three months or more before enrollment

Must not have

Prior celiac plexus block or other neurolytic pain control treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 4 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will evaluate auricular point acupressure (APA) on chemotherapy-induced neuropathy (CIN), with the goal of understanding its efficacy and underlying mechanism(s).

Who is the study for?

This trial is for cancer patients over 18 who've finished chemotherapy with specific drugs at least three months ago and are experiencing moderate to severe neuropathy pain or numbness. It's not for those using investigational pain agents, drug delivery implants, have latex allergies, prior neurolytic treatments, or pre-existing conditions causing similar symptoms.

What is being tested?

The study tests Auricular Point Acupressure (APA) for managing chemotherapy-induced neuropathy. Participants will be randomly assigned to receive APA via a virtual app or in-person training, sham APA as a placebo control, or usual care without APA intervention.

What are the potential side effects?

Since the intervention involves non-invasive acupressure rather than medication, significant side effects are not anticipated. However, some participants might experience minor discomfort or skin irritation at the site of acupressure application.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been treated with specific cancer drugs like platinum or taxanes.

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I finished my chemotherapy over three months ago.

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I have nerve damage from chemotherapy or it worsened after treatment.

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I have had pain, numbness, or tingling in my limbs rated 4 or higher last week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had a celiac plexus block or similar pain treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in numbness as assessed by the Brief Pain Inventory

Change in pain severity as assessed by the Brief Pain Inventory

Change in physical function as assessed by Patient-Reported Outcomes Measurement Information System (PROMIS) 29

+1 more

Secondary study objectives

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

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

Change of brain activity as assessed by fMRI Neuroimaging

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Active Control

Group I: Virtual Auricular Point Acupressure (vAPA)Experimental Treatment2 Interventions

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.

Group II: Auricular Point Acupressure (APA)Experimental Treatment2 Interventions

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.

Group III: Usual Care ControlActive Control1 Intervention

Usual Care arm will continue with their usual care.

0 / 5Eligibility criteria met