Daily Hand-Held Vibration Therapy

Официальное название

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

Обзор

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.

Вмешательства

• Устройство Vibration therapy
  vibration therapy using hand held vibration device

Первичные конечные точки

• Feasibility of recruitment- percentage of patients who agree to participate in the study after screening [Срок оценки: recruitment period (up to 5 year after study starts)]
• Feasibility of compliance- percentage of vibration therapy sessions completed [Срок оценки: 4 weeks]
• Acceptability of Intervention- percentage of patients who answer agree on acceptability form [Срок оценки: 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 [Срок оценки: baseline, week 1, week 2, week 3, week 4]

Вторичные конечные точки (2)

• Change in CIPN Severity via the CIPN20 questionnaire scores [Срок оценки: 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 [Срок оценки: baseline, week 4, week 8]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 3 центра

• Indiana University Health West — Avon
• Indiana University Melvin & Bren Simon Cancer Center — Indianapolis
• IU Health Joe & Shelly Schwarz Cancer Center — Indianapolis

Идентификаторы

NCT: NCT04207437 · IUSCC-0677

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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