Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis.

Evaluation of Photobiomodumation Using LED Lamp as a Curative Treatment for Oral or Oropharyngeal Mucositic Inducted by Radiation Therapy

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.

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.

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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