Daily Hand-Held Vibration Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 18 years or older at enrollment

• Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization

• Have completed chemotherapy ≥ 60 days prior to enrollment

• 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)

• 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

• If solid tumor cancer, must have non-metastatic cancer

• Agree to return to clinic for required study related measurements at specified intervals

Locations
United States
Indiana
Indiana University Health West
RECRUITING
Avon
Indiana University Melvin & Bren Simon Cancer Center
RECRUITING
Indianapolis
IU Health Joe & Shelly Schwarz Cancer Center
RECRUITING
Indianapolis
Contact Information
Primary
Malori Pojar
mpojar@iu.edu
(317) 274-0899
Backup
Lacy Slayton
lslayton@iu.edu
(317) 278-6718
Time Frame
Start Date: 2021-12-06
Estimated Completion Date: 2026-01
Participants
Target number of participants: 16
Treatments
Experimental: Vibration Therapy
Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Indiana Clinical and Translational Sciences Institute
Leads: Indiana University

This content was sourced from clinicaltrials.gov