Clinical trial NCT04207437: Daily Hand-Held Vibration Therapy
Official title: Daily Hand-Held Vibration Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuropathy
Cancer
Chemotherapeutic Drug - Induced Nephropathy
Chemotherapeutic Toxicity
Keywords: Neuropathy
Vibration
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Indiana Clinical and Translational Sciences Institute
First posted: 2019-12-20
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of recruitment- percentage of patients who agree to participate in the study after screening
timeFrame: recruitment period (up to 1 year after study starts)
measure: Feasibility of compliance- percentage of vibration therapy sessions completed
timeFrame: 4 weeks
measure: Acceptability of Intervention- percentage of patients who answer agree on acceptability form
timeFrame: 4 weeks
measure: Change in the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy twenty-item scale (CIPN20) scores
timeFrame: baseline, week 1, week 2, week 3, week 4
Secondary outcomes:
measure: Change in CIPN Severity via the CIPN20 questionnaire scores
timeFrame: baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8
measure: Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale
timeFrame: baseline, week 4, week 8
Other outcomes:
Locations:
city: Avon
country: United States
facility: Indiana University Health West
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Melvin & Bren Simon Cancer Center
state: Indiana
city: Indianapolis
country: United States
facility: IU Health Joe & Shelly Schwarz Cancer Center
state: Indiana
Study officials:
affiliation: Indiana University
name: Erin Newton, MD
role: PRINCIPAL_INVESTIGATOR
References: