Evaluation of Photobiomodumation Using LED Lamp as a Curative Treatment for Oral or Oropharyngeal Mucositic Inducted by Radiation Therapy
概览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Mucositis assessment
概览
简要总结
This is a monocentric, prospective, non-comparative phase II study with minimal risks and constraints. The study will aim to assess the curative treatment of radio-induced mucositis by photobiomodulation using LED lamp.
详细描述
The aim of this study is to assess the effectiveness of the treatment of radio- or radio-chemotherapy-induced early stage mucositis (stage 1 and 2) by photobiomodulation using LED lamp (PLED) in terms of controlling the mucositis assessed at the end of radiotherapy or radio-chemotherapy treatment.
Other objectives of the study include:
- To assess the pain evolution over-time, both overall over the evaluation period until the end of radiotherapy and at each session
- To assess the needs of level 3 analgesics (morphine, oxycodone, fentanyl, hydromorphone) during the PLED protocol.
- To assess the quality of life variation between inclusion and the end of treatment by radiotherapy or radio-chemotherapy.
- To estimate the frequency of radiotherapy or radio-chemotherapy treatment (temporary or permanent interruption, dose modification), and eventually, the reason of this modification.
- To assess the feasibility of photobiomodumation by LED (PLED) in this context.
- To assess the tolerability of photobiomodumation by LED (PLED) in a short term.
- To assess the frequency of the needs of nutritional support by nasogastric tube or gastrostomy tube during the PLED protocol.
- To assess the weight and general condition variation during the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age \> 18 years old
- •With squamous cell carcinoma of the head and/or neck
- •Stage 1 or 2 mucositis (NCI-CTCAE v5), wich means a mucositis not requiring an enteral nutrition management (solid or liquid alimentation possible, including with feed supplements) in week 2 to 4 in relation to the beginning of radiotherapy.
- •During treatment by radiotherapy, with or without concomitant chemotherapy
- •Patient affiliated to a social security system
- •Patient who signed the informed consent for this study
排除标准
- •Radiotherapy treatment completed
- •Stage 3 or higher mucositis already installed
- •History of skin porphyria or lupus erythematosus
- •Concomitant or within 7 days prior to inclusion, at least one of following drugs : fluoroquinolones, cycline, methotrexate, auranofine
- •Enteral nutrition support in progress
- •Pregnant or breast-feeding woman
- •Patient under guardianship or curatorship
结局指标
主要结局
Mucositis assessment
时间窗: Change from baseline mucositis assessment at 7 weeks
The mucositis will be assessed at least once a week between the inclusion and the end of treatment by radiotherapy or radio-chimiotherapy. It will be graded according to the NCI-CTCAE v5 scale. The scale ranging from 1 to 5. Where 1 is mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated and where 5 is death related to adverse event. We will consider as success the non-occurrence of stage 3 or higher mucositis between the inclusion and the end of radiotherapy. All patient presenting stage 3 or higher mucositis, which means, aphagia leading to an indication of nutritional support between the inclusion and the end of radiotherapy will be considered as a failure. A patient receiving less than 60 grey for an other reason than mucositis will be concidered as not assessable for the primery outcome.
次要结局
- Starting a level 3 analgesic treatment (morphine, oxycodone, fentanyl, hydromorphone)(Through study completion, an average of 7 weeks)
- Quality of Life (QoL)(At baseline and at week 7 (end of the study))
- Modification of treatment by radiotherapy or radio-chemotherapy(Through study completion, an average of 7 weeks)
- Interruption of sessions(Through study completion, an average of 7 weeks)
- Number of side effects(Through study completion, an average of 7 weeks)
- Nutritional support by nasogastric tube or gastrostomy tube(Through study completion, an average of 7 weeks)
- Weight variation(Every week during the study (7 weeks))
- Performance status(Every week during the study (7 weeks))
- Pain related to the mucositis(At baseline, during each session - at least 3 times a week during 7 weeks, at the end of the study (week 7))