Daily Hand-Held Vibration Therapy for Chemotherapy-Induced Neuropathy
This study is testing a daily 3-minute hand-held vibration therapy to see if it can safely and practically reduce nerve damage (neuropathy) in the hands caused by chemotherapy. You may be able to join if you are 18 or older, have completed chemotherapy at least 60 days ago, and received specific neurotoxic chemotherapy drugs like Paclitaxel (at a cumulative dose of 300 mg/m2 or more) or Docetaxel. The researchers want to know if people are willing to join, if they can complete the vibration therapy sessions, and if they find the treatment acceptable. This study is currently unclear on its recruitment status.
- Study design
- This is an interventional pilot study with a planned enrollment of 16 participants. It is designed to evaluate the safety and practicality of the vibration therapy.
- What's involved
- You would use a hand-held vibration device for 3 minutes daily. The study will assess your compliance and acceptability of the intervention over 4 weeks.
- Compensation
- Not stated in the trial record.
- Follow-up
- The study measures feasibility of recruitment for up to 5 years after the study starts, and feasibility of compliance and acceptability of intervention at 4 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Daily Hand-Held Vibration Therapy
At a glance
Conditions
Where it's being run
3 sites across 1 statesStudy leadership
- Erin Newton, MD · PRINCIPAL_INVESTIGATOR · Indiana University
Who to contact
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What this trial measures
- Feasibility of recruitment- percentage of patients who agree to participate in the study after screeningrecruitment period (up to 5 year after study starts)
- Feasibility of compliance- percentage of vibration therapy sessions completed4 weeks
Compliance with the daily vibration therapy sessions will be evaluated using data from a Daily Compliance Form Researchers will calculate the percentage of sessions that were completed calculated for each participant, on each hand. Participant compliance with the intervention will be considered acceptable if participants complete ≥ 80% of the sessions they were assigned.
- Acceptability of Intervention- percentage of patients who answer agree on acceptability form4 weeks
percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form
- Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scoresbaseline, week 1, week 2, week 3, week 4
CIPN 20 questionnaire scores will be compared to baseline weekly to identify an increase of 30% during the intervention period. The CIPN scores range from 20 to 80 with 80 being consistent with the most severe neuropathy symptoms