Photobiomodulation Therapy Using the MuReva Phototherapy System to Demonstrate Safety and Reduce the Incidence of Oral Mucositis in Adult Patients With Head and Neck Cancer Receiving Radiation Therapy With or Without Concurrent Chemotherapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 85
- 试验地点
- 23
- 主要终点
- IThe primary effectiveness endpoint is the severity of oral mucositis at week 6 of radiation treatment according to the Oral Mucositis Index (OMI) score.
研究概览
简要总结
The overall purpose of this clinical study is to evaluate safety and efficacy of the MuReva Phototherapy System with a light delivery mouthpiece to reduce the severity of oral mucositis (OM) in adult patients with squamous cell carcinoma of the oral cavity, oropharynx, tonsils and base of tongue receiving radiation therapy with or without concurrent chemotherapy.
详细描述
Study Design: A prospective, multi-center, randomized, double-blind, placebo controlled, adaptive sample size, two-treatment parallel, pivotal clinical study.
Protocol-eligible subjects will be randomized in a 1:1 allocation to receive either the active MuReva Phototherapy System or a sham control. Both the subjects and clinician evaluating the patients will be blinded to the treatment assignments. The sham device will be placed in the patient's mouth and operated in the same manner as the active device, but not deliver any therapy.
Subjects will begin device treatment sessions on the first day of radiation treatment (RT) and will continue to receive once daily treatments prior to RT with their assigned device for 5 days per week for the duration of their RT treatment (approximately 6 to 8 weeks, for a total of 30 to 40 device sessions depending on the standard of care regimen for the type of cancer). Each device treatment session will last approximately 10 minutes in total. Light therapy parameters for the MuReva Phototherapy System will be as follows for all subjects receiving active light therapy: 660nm, 2-12 J/cm2 nominal fluence. Subjects who stay on RT treatment past 6 weeks will continue to receive treatment with their assigned devices up through 8 total weeks of treatment (for a maximum total of 40 phototherapy sessions). In addition, all subjects, regardless of randomization, will be kept on standard oral care, oral hygiene and oral pain protocols.
All subjects will visit the study site once during the Screening period (Days -28 to 1) and an anticipated 30 to 40 times during the treatment period (i.e., 5 days during each of the 6-8 RT treatment weeks). Weekly, subjects will be evaluated for oral mucositis and for device safety. The weekly assessments will continue through the final RT session. A post-therapy assessment will be done approximately 2 weeks after completion of RT. At the conclusion of this assessment each subject's participation in the study will be complete.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
The sponsor, clinical research organization (CRO), subjects, research staff and Investigators performing the weekly OM evaluations for the study will be blinded to the treatment assignments. Subjects will be mandated to use light-blocking eyewear.
Only the research staff delivering treatment will be unblinded. No other personnel or visitors will be allowed in the treatment room during active/sham treatment.
The Investigators will not administer the daily treatment and will not visit or observe the patient during device use in order to remain blinded. The Investigators will also remain blinded to the patients' responses to the weekly Self-Assessments.
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
IThe primary effectiveness endpoint is the severity of oral mucositis at week 6 of radiation treatment according to the Oral Mucositis Index (OMI) score.
时间窗: approximately 6 weeks after patient begins radiation therapy
The primary effectiveness endpoint of the study is the severity of oral mucositis as assessed by the Oral Mucositis Index (OMI) score, on a scale of 0-60.
次要结局
- Changes in overall quality of life over the 6-week treatment period(difference between baseline and (approximately) 6 weeks after patient begins radiation therapy)
- World Health Organization (WHO) Oral Toxicity Scale at week 6(approximately 6 weeks after patient begins radiation therapy)