Actively Recruiting
Daily Hand-Held Vibration Therapy for Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study
Led by Indiana University · Updated on 2026-05-28
16
Participants Needed
3
Research Sites
4 weeks
Total Duration
On this page
Sponsors
I
Indiana University
Lead Sponsor
I
Indiana Clinical and Translational Sciences Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of a daily 3-minute hand-held vibration therapy to reduce the severity of chemotherapy-induced peripheral neuropathy (CIPN) in the hands. This pilot study aims to gather early data on the feasibility, safety, and potential benefits of this therapy to improve CIPN-related quality of life. The goal is to use these results to support future trials exploring vibration therapy as a treatment option for CIPN. Participants will use a hand-held vibrating device daily, holding it on each hand for 3 minutes over a 4-week period. This intervention is designed to be simple and self-administered. There are no comparator groups mentioned, and the focus is on monitoring the therapy's acceptability and compliance during this time. During the study, researchers will track recruitment rates, adherence to therapy sessions, and patient acceptance of the intervention. They will measure changes in CIPN severity and quality of life using validated questionnaires at baseline and weekly throughout the 4 weeks, with additional follow-ups up to 8 weeks. Participants must return to the clinic for assessments at specified intervals to support these evaluations.
CONDITIONS
Brief Title
Daily Hand-Held Vibration Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older at enrollment
- Able to provide informed consent and HIPAA authorization
- Completed chemotherapy at least 60 days before enrollment
- Exposed to neurotoxic chemotherapy with specified agents at minimum cumulative doses
- Sensory CIPN in hands at Grade 2 or higher per NCI-CTC-AE Version 5.0 at least 60 days post-chemotherapy
- Non-metastatic solid tumor cancer if applicable
- Agree to attend clinic visits for study measurements
You will not qualify if you...
- Pre-existing neuropathy in hands unrelated to chemotherapy (e.g., carpal tunnel syndrome)
- Known diabetes mellitus diagnosis
- Contraindications to hand vibration therapy such as deep venous thrombosis or skin infection
- Receiving concurrent radiation therapy to the upper extremity
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants hold a hand-held vibrating device for 3 minutes on each hand daily for 4 weeks as part of the therapy.
Weekly visits for up to 4 weeks
Duration - 4 weeks
Participants are monitored for changes in neuropathy symptoms and quality of life after the therapy ends.
Visits at weeks 5, 6, 7, and 8
Trial Site Locations
Total: 3 locations
1
Indiana University Health West
Avon, Indiana, United States, 46123
Actively Recruiting
2
Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
3
IU Health Joe & Shelly Schwarz Cancer Center
Indianapolis, Indiana, United States, 46202
Actively Recruiting
Research Team
C
Cheri West, RN
L
Lacy Slayton
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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