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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04207437
Other study ID # IUSCC-0677
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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