| NCT ID | NCT04207437 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Indiana University |
| Condition | Neuropathy |
| Study Type | INTERVENTIONAL |
| Enrollment | 16 participants |
| Start Date | 2021-12-06 |
| Primary Completion | 2026-09 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 16 participants in total. It began in 2021-12-06 with a primary completion date of 2026-09.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Erin Newton, MD
PRINCIPAL INVESTIGATOR
Indiana University
Frequently Asked Questions
Who can join the NCT04207437 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Neuropathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04207437 currently recruiting?
Yes, NCT04207437 is actively recruiting participants. Contact the research team at chawest@iu.edu for enrollment information.
Where is the NCT04207437 trial being conducted?
This trial is being conducted at Avon, United States, Indianapolis, United States, Indianapolis, United States.
Who is sponsoring the NCT04207437 clinical trial?
NCT04207437 is sponsored by Indiana University. The principal investigator is Erin Newton, MD at Indiana University. The trial plans to enroll 16 participants.