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

Oral Cancer Clinical Trial

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

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04251949
Study type Interventional
Source Centre Oscar Lambret
Contact
Status Completed
Phase Phase 2
Start date March 19, 2021
Completion date September 19, 2022
View Details
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