Study Summary
This trial is testing if a 3-minute daily hand-held vibration therapy can reduce the severity of Chemotherapy-Induced Peripheral Neuropathy (CIPN) in the hands and improve quality of life.
Eligible Conditions
- Chemotherapy Toxicity
- Cancer
- Neuropathy
- Chemotherapy-Induced Nephropathy
Treatment Effectiveness
Effectiveness Progress
Study Objectives
4 Primary · 2 Secondary · Reporting Duration: recruitment period (up to 1 year after study starts)
4 weeks
Acceptability of Intervention- percentage of patients who answer agree on acceptability form
Feasibility of compliance- percentage of vibration therapy sessions completed
Week 4
Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores
Week 8
Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale
Week 8
Change in CIPN Severity via the CIPN20 questionnaire scores
Year 1
Feasibility of recruitment- percentage of patients who agree to participate in the study after screening
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Vibration Therapy
1 of 1
Experimental Treatment
16 Total Participants · 1 Treatment Group
Primary Treatment: Vibration therapy · No Placebo Group · N/A
Vibration Therapy
Device
Experimental Group · 1 Intervention: Vibration therapy · Intervention Types: DeviceTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vibration therapy
2011
N/A
~50
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: recruitment period (up to 1 year after study starts)
Who is running the clinical trial?
Indiana UniversityLead Sponsor
877 Previous Clinical Trials
759,539 Total Patients Enrolled
Indiana Clinical and Translational Sciences InstituteOTHER
18 Previous Clinical Trials
5,460 Total Patients Enrolled
Erin Newton, MD4.796 ReviewsPrincipal Investigator - Indiana University
Medical School - Aga Khan University Medical College, Bachelor of Medicine, Bachelor of Surgery
West Virginia University (Residency)
1 Previous Clinical Trials
5Patient Review
The office staff were lovely and I didn't have to wait long before seeing the doctor. Dr. Sher was so helpful and answered all my questions thoroughly.
Eligibility Criteria
Age 18+ · All Participants · 7 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have non-metastatic cancer.
Continue to display evidence of sensory CIPN in the hands rated at a Grade ≥ 2 according to the NCI-CTC-AE, Version 5.0, ≥ 60 days post-chemotherapy.
You are 18 years or older at enrollment.\n
You are able to provide informed consent and HIPAA authorization.
You agree to return to the clinic for the required study related measurements at the specified intervals.
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Conditions
Cancer Related
Treatments