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 Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
16
vibration therapy using hand held vibration device
Indiana University Health West
Avon, Indiana, United States
RECRUITINGIndiana University Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States
RECRUITINGIU Health Joe & Shelly Schwarz Cancer Center
Indianapolis, Indiana, United States
RECRUITINGFeasibility of recruitment- percentage of patients who agree to participate in the study after screening
Time frame: recruitment period (up to 5 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.
Time frame: 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
Time frame: 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
Time frame: baseline, week 1, week 2, week 3, week 4
Change in CIPN Severity via the CIPN20 questionnaire scores
Summary statistics for the weekly CIPN-20 (n, mean, standard deviation, median, minimum, maximum)
Time frame: 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
Time frame: baseline, week 4, week 8
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.