Digestive System Diseases

Mouth and Tooth Diseases

All Conditions

Neoplasms

Ear, Nose, and Throat Diseases

Rare Diseases

Mucositis

Mouth Neoplasms

Oropharyngeal Neoplasms

Mouth Diseases

Stomatognathic Diseases

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Otorhinolaryngologic Diseases

Oral Cancer

Lip and Oral Cavity Cancer

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.

LED photobiomodulation

Xavier XL LIEM, MD

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.

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

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.

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.

Percentage of patients starting a level 3 analgesic treatment during the study.

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.

Percentage of patient with an interruption (temporary or permanent) or dose modification.

Percentage of patient with session interruption, temporary or permanent.

Percentage of patients with side effect probably related to the photobiomodulation LED treatment.

Percentage of patients with needs of nutritional support by nasogastric tube or gastrostomy tube.

Weighting at each visit and comparison between the values

Assessment of the general condition by the scale of performance status (OMS) from 0 to 5.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis.	NCT04251949	Oral Cancer Oropharyngeal C...	LED photobiomod...	18 Years -	Centre Oscar Lambret
Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis.	NCT04251949	Oral Cancer Oropharyngeal C...	LED photobiomod...	18 Years -	Centre Oscar Lambret

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