Daily Hand-Held Vibration Therapy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
18 years or older at enrollment
Able to provide informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization
Have completed chemotherapy ≥ 60 days prior to enrollment
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)
Disqualifiers
Have pre-existing neuropathy affecting the hands not related to chemotherapy (e.g., carpal tunnel syndrome, nerve compression, etc.)
Known diagnosis of diabetes mellitus.
Known contraindications for vibration therapy to hands, including deep venous thrombosis of the upper extremity or ongoing skin infection.
Will be receiving concurrent radiation of the upper-extremity
Trial design
Design model
Single group
Treatments tested in this trial
Vibration therapy
Devicevibration therapy using hand held vibration device
Treatment groups
16 Participants
are divided into 1 treatment groupGroup A: Vibration TherapyExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility 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)2
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 weeks3
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 weeks4
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 4Secondary outcomes
1
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 82
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 8Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Indiana University
Lead sponsor
Indiana Clinical and Translational Sciences Institute
Collaborator
Source ClinicalTrials.gov