Overview

Eligibility

Design Details

Arms & Interventions

Outcome Measures

Trial Sites

Source: NCT04207437

Recruiting

Daily Hand-Held Vibration Therapy

Interventional

Phase not listed

Indiana University Melvin & Bren Simon Cancer Center

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.

Treatment Category

Device

Required Mutations

None

Trial Started

2021-12-06

Last Updated by Sponsor

2025-07-28

Estimated Completion

2025-12-01

Eligibility

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

Do you think this trial is incorrectly appearing?

Design Details

AllocationN/A

Intervention ModelSingle Group Assignment

MaskingNone (Open Label)

Number to Enroll16

Arms & Interventions

Arms

Interventions

Type: Experimental

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

Interventions:

Vibration therapy

Outcome Measures

Primary Outcome Measures

Feasibility of recruitment- percentage of patients who agree to participate in the study after screeningrecruitment period (up to 1 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

Secondary Outcome Measures

Change in CIPN Severity via the CIPN20 questionnaire scoresbaseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8

Summary statistics for the weekly CIPN-20 (n, mean, standard deviation, median, minimum, maximum)

Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scalebaseline, week 4, week 8

Descriptive statistics (frequency and percentage for each category, mean and standard deviation of scores assigned to each category (range: 0-7)) will be used to describe the CIPN-related QOL participants have on each of the three categories related to quality of life

Interested in participating?

Learn more about this trial and whether you may be eligible to participate.

Bookmark trial

Share Trial By Email

Download Trial

Do you think this trial is incorrectly appearing?

Report Trial

Download Trial

Trial Sites

This study has 3 trial sites

Indiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, US

Recruiting

Indianapolis, Indiana, 46202 US

Indiana University Melvin & Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, 46202 US

IU Health Joe & Shelly Schwarz Cancer Center

Recruiting

Avon, Indiana, 46123 US

Indiana University Health West

Loading Maps...