Daily Hand-Held Vibration Therapy

• Sponsor: Indiana University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04207437
• Collaborator: Indiana Clinical and Translational Sciences Institute (Other)
• Enrollment: 16
• Locations: 2
• Arm: 1
• Anticipated Duration (Months): 47.6
• Patients Per Site: 8
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neuropathy; Cancer; Chemotherapeutic Drug - Induced Nephropathy; Chemotherapeutic Toxicity	Device: Vibration therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 16 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Subjects will be instructed to perform 3-minutes of vibration therapy per hand each day using a hand held vibration device for 4 weeks. The amount of time that subjects perform vibration therapy will be recorded on their Daily Compliance form and subjects will complete questionnaires daily and weekly.Subjects will be instructed to perform 3-minutes of vibration therapy per hand each day using a hand held vibration device for 4 weeks. The amount of time that subjects perform vibration therapy will be recorded on their Daily Compliance form and subjects will complete questionnaires daily and weekly.
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Daily Hand-Held Vibration Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study
• Actual Study Start Date: Feb 12, 2020
• Anticipated Primary Completion Date: Dec 31, 2023
• Anticipated Study Completion Date: Jan 31, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Feasibility of recruitment- percentage of patients who agree to participate in the study after screening [recruitment period (up to 1 year after study starts)]

2. Feasibility of compliance- percentage of vibration therapy sessions completed [4 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.

3. Acceptability of Intervention- percentage of patients who answer agree on acceptability form [4 weeks]

   percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form

4. Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores [baseline, 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

1. Change in CIPN Severity via the CIPN20 questionnaire scores [baseline, 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)

2. Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale [baseline, 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana	United States	46202
2	IU Health Joe & Shelly Schwarz Cancer Center	Indianapolis	Indiana	United States	46202

Sponsors and Collaborators

• Indiana University
• Indiana Clinical and Translational Sciences Institute

Investigators

• Principal Investigator: Erin Newton, MD, Indiana University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Erin Newton, MD, Assistant Professor of Clinical Medicine, Indiana University
• ClinicalTrials.gov Identifier: NCT04207437
• Other Study ID Numbers: IUSCC-0677
• First Posted: Dec 20, 2019
• Last Update Posted: Jun 21, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Keywords provided by Erin Newton, MD, Assistant Professor of Clinical Medicine, Indiana University: Neuropathy; Vibration
• Additional relevant MeSH terms: Peripheral Nervous System Diseases; Kidney Diseases

Study Results

No Results Posted as of Jun 21, 2022