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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 moreSecondary outcome measures
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 moreTrial 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.
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,666 Previous Clinical Trials
40,925,780 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
2,974 Previous Clinical Trials
1,789,121 Total Patients Enrolled
Johns Hopkins UniversityOTHER
2,266 Previous Clinical Trials
14,837,272 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with specific cancer drugs like platinum or taxanes.I have had painful tingling in my limbs before chemotherapy due to other causes.I finished my chemotherapy over three months ago.I have had a celiac plexus block or similar pain treatment.I haven't used experimental pain medication in the last 30 days.I am 18 years old or older with cancer.I have nerve damage from chemotherapy or it worsened after treatment.I have had pain, numbness, or tingling in my limbs rated 4 or higher last week.
Research Study Groups:
This trial has the following groups:- Group 1: Virtual Auricular Point Acupressure (vAPA)
- Group 2: Auricular Point Acupressure (APA)
- Group 3: Usual Care Control
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this experimental trial still available?
"According to the clinicaltrials.gov database, this experiment is actively seeking out participants. It was first published on July 8th 2021 and most recently updated on November 11th 2022."
Answered by AI
What is the aggregate amount of individuals participating in this clinical investigation?
"Correct. According to clinicaltrials.gov, this trial has been actively recruiting since July 8th 2021 and requires 240 participants at a single centre. The details were last updated on November 11th 2022."
Answered by AI
What outcomes is this clinical trial hoping to accomplish?
"This clinical trial, which will span a period of up to 4 months, aims to quantify the change in tingling experienced by participants using the Brief Pain Inventory. Secondary goals include ascertaining changes in pain sensitivity through Qualitative Sensory Testing (QST) and anti-inflammatory/pro-inflammatory cytokines measured via serum biomarkers. The QST battery involves light touch sensation tests, threshold responses conducted with randomized orderings, temporal summation measurements combined into a central sensitization index for statistical analyses; while blood samples collected by standard phlebotomy procedures are used to detect any alterations in cytokine levels greater than 50% of baseline"
Answered by AI
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