NCT04251949

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (actual)
• Sponsor: Centre Oscar Lambret · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Oral Cancer
• Oropharyngeal Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-03-19
• Primary completion: 2022-09-19
• Completion: 2022-09-19
• First posted: 2020-02-05
• Last updated: 2026-03-18

Locations

1 site across 1 country: France