Clinical trial · Interventional
Daily Hand-Held Vibration Therapy
Daily Hand-Held Vibration Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this pilot study is to determine the safety and feasibility of a daily 3-minute hand-held vibration therapy intervention to reduce the severity of CIPN in the hands. The investigators hypothesize that daily vibration therapy can reduce the severity of patient's CIPN in their hands and improve CIPN-related quality of life. The hope is that results from this study will provide early data on the feasibility, efficacy, and most importantly, safety, of daily 3-minute hand-held vibration therapy needed to justify future clinical trials examining vibration therapy as a potential option for treating CIPN in the future.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Chemotherapeutic Drug - Induced Nephropathy | — | UNRESOLVED | — |
| Chemotherapeutic Toxicity | — | UNRESOLVED | — |
| Neuropathy | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Vibration therapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Vibration Therapy
- description
- Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks.
- interventionNames
- Device: Vibration therapy
Primary outcomes (4)
- measure
- Feasibility of recruitment- percentage of patients who agree to participate in the study after screening
- timeFrame
- recruitment period (up to 5 year after study starts)
- measure
- Feasibility of compliance- percentage of vibration therapy sessions completed
- timeFrame
- 4 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18 years or older at enrollment 2. Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization 3. Have completed chemotherapy ≥ 60 days prior to enrollment 4. Were exposed to neurotoxic chemotherapy with one or more of the following agents in the following doses: Paclitaxel (cumulative dose: ≥ 300 mg/m2) Docetaxel (cumulative dose: ≥ 100 mg/m2) Nab-paclitaxel (cumulative dose: ≥ 750 mg/m2) Oxaliplatin (cumulative dose: ≥ 510 mg/m2) Carboplatin (cumulative dose: ≥ 600 mg/m2) Cisplatin (cumulative dose: ≥ 200 mg/m2) Vincristine (cumulative dose: ≥ 4 mg/m2) Bortezomib (cumulative dose: ≥ 16 mg/m) 5. Continue to display evidence of sensory CIPN in the hands rated at a Grade ≥ 2 according the National Cancer Institute's Common Toxicity Criteria-Adverse Events (NCI-CTC-AE, Version 5.0) Scale ≥ 60 days post-chemotherapy 6. If solid tumor cancer, must have non-metastatic cancer 7. Agree to return to clinic for required study related measurements at specified intervals Exclusion Criteria: 1. Have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.) 2. Known diagnosis of diabetes mellitus. 3. Known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection. 4. Will be receiving concurrent radiation of the upper-extremity
References
Publications (0)
Data not yet available