Light Therapy for Chemotherapy Induced Peripheral Neuropathy in Childhood Cancer Survivors

Обзор

The purpose of this study is to determine feasibility and acceptability of a six-week at-home light therapy protocol in childhood cancer survivors, to identify facilitators and barriers to implementing this intervention, and to measure signs and symptoms of Chemotherapy Induced Peripheral Neuropathy (CIPN) at baseline and following completion of the at-home light therapy protocol.

Подробное описание

This prospective single-arm pilot study will assess the feasibility of a 6-week at-home light therapy intervention for CIPN. Survivors of childhood cancer (\<21 years at diagnosis), ages five years or older at the time of survivorship clinic visit, with a history of exposure to vinca alkaloid, platinum, or other chemotherapeutic agent that can cause CIPN, will be included if they have CIPN (defined as a score of four or higher on the pediatric modified Total Neuropathy Score for survivors \<18 years old at evaluation, or the modified Total Neuropathy Score for survivors 18 years or older at evaluation). The primary outcome of the study will be feasibility of the at-home protocol, measured as proportion of survivors who complete at least 12 at-home light therapy sessions, with ≥70% of survivors completing 12 or more sessions indicating feasibility. Secondary outcomes include 1) Proportion of survivors satisfied with intervention, measured as a mean score of 3 or higher on a 4-point Likert-scale survey 2) Facilitators and barriers to implementation of light-therapy, assessed by semi-structured qualitative interviews with 5-10 survivors who adhered and did not adhere to the protocol, and 3) change in neuropathy symptoms (measured by change in modified Total Neuropathy Score or pediatric-modified Total Neuropathy Score, and gait speed) from baseline to 1 week post intervention.

Вмешательства

• Устройство Anodyne Therapy System
  Survivors will be provided the Anodyne Therapy System Model 120 to use as part of a 6-week at-home light therapy intervention. Participants will be instructed on where apply the device based on location of their symptoms, and will be instructed to use the device for 15 minutes per day, 3 days per week. Proper use of the device will be demonstrated in clinic by a trained physical therapist or study team member.

Первичные конечные точки

• Feasibility of light therapy protocol [Срок оценки: 7 weeks]

Вторичные конечные точки (4)

• Acceptability of light therapy for CIPN [Срок оценки: 7 weeks]
• Barriers and facilitators [Срок оценки: 7 weeks]
• Change in gait efficiency [Срок оценки: baseline and 7 weeks]
• Changes in neuropathy symptoms [Срок оценки: baseline and 7 weeks]

Критерии участия

Критерии включения

• History of childhood cancer (<21 years of age at diagnosis)
• Current age five years or older (due to availability of validated measures for CIPN in this age group)
• History of exposure to vinca alkaloid, platinum, or other chemotherapeutic agent that can cause CIPN
• CIPN as assessed by a trained physical therapist defined as a score of four or higher on the ped-mTNS (for survivors <18 years old at evaluation), or the mTNS (for survivors 18 years or older at evaluation)

Критерии исключения

• Currently Pregnant or lactating (by patient report, at initiation or at any point of the study)
• Inability to sit still for at least 15 minutes
• Diagnosis of neuropathy prior to cancer treatment
• Active cancer diagnosis or cancerous skin lesion
• Central nervous system tumor (due to lack of validated measures for CIPN in this population)
• Cancer lesion or open wound in the area to be treated, or any condition that can potentially be made worse by the correct or incorrect use of the device.

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

Другое

Центры проведения

США · 2 центра

• Yale New Haven Health Smilow York Street Hospital — New Haven
• Yale New Haven Health Park Avenue Medical Center — Trumbull

Идентификаторы

NCT: NCT07019259 · 2000038498

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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