Daily Hand-Held Vibration Therapy

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04207437
• Other study ID #: IUSCC-0677
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2021
• Est. completion date: January 31, 2025

Study information

• Verified date: July 2023
• Source: Indiana University
• Contact: Nada Kassem
• Phone: 317-278-5238
• Email: nakassem[@]iu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 16
• Est. completion date: January 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

• Cancer
• Chemotherapeutic Drug - Induced Nephropathy
• Chemotherapeutic Toxicity
• Kidney Diseases
• Neuropathy
• Peripheral Nervous System Diseases

Intervention

Device:
• Vibration therapy
vibration therapy using hand held vibration device

Locations

Country	Name	City	State
United States	Indiana University Melvin & Bren Simon Cancer Center	Indianapolis	Indiana
United States	IU Health Joe & Shelly Schwarz Cancer Center	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University	Indiana Clinical and Translational Sciences Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of recruitment- percentage of patients who agree to participate in the study after screening		recruitment period (up to 1 year after study starts)
Primary	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
Primary	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
Primary	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	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
Secondary	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