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NCT Number: NCT04207437

Daily Hand-Held Vibration Therapy

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University Health West, Avon, Indiana, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vibration therapy

Device

vibration therapy using hand held vibration device

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

    Time frame: 4 weeks

    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.

  3. Acceptability of Intervention- percentage of patients who answer agree on acceptability form

    Time frame: 4 weeks

    percentage of participants who answer "somewhat agree," "agree," or "strongly agree" on the intervention acceptability form

  4. 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

    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

Secondary outcomes

  1. Change in CIPN Severity via the CIPN20 questionnaire scores

    Time frame: baseline, weeks 1, 2, 3, and 4, 5, 6, 7, and week 8

    Summary statistics for the weekly CIPN-20 (n, mean, standard deviation, median, minimum, maximum)

  2. Change in CIPN related Quality of Life via the Chemotherapy Induced Peripheral Neuropathy Quality of Life Scale

    Time frame: baseline, week 4, week 8

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Cheri West, RN

CONTACT

[email protected]

317-278-3021

Lacy Slayton

CONTACT

[email protected]

(317) 278-6718

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Indiana Clinical and Translational Sciences Institute

Registry information

Official study title

Daily Hand-Held Vibration Therapy for the Treatment of Chemotherapy Induced Peripheral Neuropathy (CIPN): A Pilot Study

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Dec 20, 2019
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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