Daily Hand-Held Vibration Therapy

Indiana University

Status: Enrolling

Conditions: Chemotherapeutic Drug - Induced Nephropathy; Chemotherapeutic Toxicity; Cancer; Neuropathy

Treatments: Device: Vibration therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04207437

IUSCC-0677

Details and patient eligibility

About

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.

Enrollment: 16 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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16 participants in 1 patient group

Vibration Therapy

Experimental group

Description:

Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks.

Treatment:

Device: Vibration therapy