Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucos… (NCT04251949) | Clinical Trial Compass
CompletedPhase 2
Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis.
France28 participantsStarted 2021-03-19
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Mucositis assessment
Timeframe: Change from baseline mucositis assessment at 7 weeks