Daily Hand-Held Vibration Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vibration therapy.
- Who it may be relevant to
- Registry conditions: Neuropathy, Cancer, Chemotherapeutic Drug - Induced Nephropathy, Chemotherapeutic Toxicity. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Daily Hand-Held Vibration Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study
Overview
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.
Interventions
- Device Vibration therapy
vibration therapy using hand held vibration device
Primary outcome measures
- 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)]
- Feasibility of compliance- percentage of vibration therapy sessions completed [Time frame: 4 weeks]
- Acceptability of Intervention- percentage of patients who answer agree on 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 [Time frame: baseline, week 1, week 2, week 3, week 4]
Secondary outcome measures (2)
- Change in CIPN Severity via the CIPN20 questionnaire scores [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 [Time frame: baseline, week 4, week 8]
Eligibility criteria
Inclusion criteria
- 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)
- 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
- If solid tumor cancer, must have non-metastatic cancer
- Agree to return to clinic for required study related measurements at specified intervals
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 3 centers
- Indiana University Health West — Avon
- Indiana University Melvin & Bren Simon Cancer Center — Indianapolis
- IU Health Joe & Shelly Schwarz Cancer Center — Indianapolis
Identifiers
NCT: NCT04207437 · IUSCC-0677