Daily Hand-Held Vibration Therapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer; Neuropathy; Chemotherapeutic Toxicity; Chemotherapeutic Drug - Induced Nephropathy
• Intervention / Treatment: Device: Vibration therapy

• Study Type: Interventional
• Enrollment (Estimated): 16
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nada Kassem; Phone Number: 317-278-5238; Email: nakassem@iu.edu

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • Indiana University Melvin & Bren Simon Cancer Center
      • Contact: Nada Kassem; Phone Number: 317-278-5238; Email: nakassem@iu.edu
    • Indianapolis, Indiana, United States, 46202
      • Recruiting
      • IU Health Joe & Shelly Schwarz Cancer Center
      • Contact: Nada Kassem; Phone Number: 317-278-5238; Email: nakassem@iu.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vibration Therapy; Patients will hold a hand held vibrating device for 3 minutes on each hand daily for 4 weeks.	Device: Vibration therapy; vibration therapy using hand held vibration device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of recruitment- percentage of patients who agree to participate in the study after screening		recruitment period (up to 1 year after study starts)
Feasibility of compliance- percentage of vibration therapy sessions completed	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.	4 weeks
Acceptability of Intervention- percentage of patients who answer agree on acceptability form	percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form	4 weeks
Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores	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	baseline, week 1, week 2, week 3, week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in CIPN Severity via the CIPN20 questionnaire scores	Summary statistics for the weekly CIPN-20 (n, mean, standard deviation, median, minimum, maximum)	baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8
Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale	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	baseline, week 4, week 8

Collaborators and Investigators

• Sponsor: Indiana University
• Collaborators: Indiana Clinical and Translational Sciences Institute
• Investigators: Principal Investigator: Erin Newton, MD, Indiana University

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2021
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: December 11, 2019
• First Submitted That Met QC Criteria: December 19, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Vibration; Neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Urologic Diseases; Neuromuscular Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Kidney Diseases; Peripheral Nervous System Diseases
• Other Study ID Numbers: IUSCC-0677

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No