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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Oral Cancer, Oropharyngeal Cancer

Intervention / Treatment
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* Procedure: LED photobiomodulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: LED photobiomodulation|1 PLED session before each radiotherapy session, until the end of the radio or radio-chemotherapy treatment. Each session will last 7 minutes. The light delivered will be preset on the lamp which will deliver a red light of a wavelength of 630nm, at a fluence of 37J/cm².|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mucositis assessment | 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. | Change from baseline mucositis assessment at 7 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain related to the mucositis | Pain will be assessed with a decimal numerical scale (END) from 0 to 10. Where 0 is no pain felt and 10 is the maximal pain felt. An estimation of the average difference between each mesure will be performed. | At baseline, during each session - at least 3 times a week during 7 weeks, at the end of the study (week 7) | 
| Starting a level 3 analgesic treatment (morphine, oxycodone, fentanyl, hydromorphone) | Percentage of patients starting a level 3 analgesic treatment during the study. | Through study completion, an average of 7 weeks | 
| Quality of Life (QoL) | The quality of life will be evaluated using the EORTC-QLQ-C30 questionnaire. This questionnaire aim to assess the quality of life of cancer and it's composed of 30 questions. In this questionnaire, the items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much. Only 2 items in the EORTC-QLQ-C30 questionnaire are scored from 1-7, where 1 is very poor and 7 is excellent. After that, questions from 31 to 65 are about H&N35, still to assess the quality of life of cancer. The items are scored from 1-4, where 1 = not at all, 2 = a little, 3 = quite a bit and 4 = very much. Only 5 items are scored from 1-2, where 1 = No and 2 = Yes. | At baseline and at week 7 (end of the study) | 
| Modification of treatment by radiotherapy or radio-chemotherapy | Percentage of patient with an interruption (temporary or permanent) or dose modification. | Through study completion, an average of 7 weeks | 
| Interruption of sessions | Percentage of patient with session interruption, temporary or permanent. | Through study completion, an average of 7 weeks | 
| Number of side effects | Percentage of patients with side effect probably related to the photobiomodulation LED treatment. | Through study completion, an average of 7 weeks | 
| Nutritional support by nasogastric tube or gastrostomy tube | Percentage of patients with needs of nutritional support by nasogastric tube or gastrostomy tube. | Through study completion, an average of 7 weeks | 
| Weight variation | Weighting at each visit and comparison between the values | Every week during the study (7 weeks) | 
| Performance status | Assessment of the general condition by the scale of performance status (OMS) from 0 to 5. | Every week during the study (7 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oral cancer, Radiotherapy, Radio-chemotherapy, Mucositis, LED photobiomodulation (PLED), Oropharyngeal cancer