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

NCT04251949 | Completed Phase 2 DMC

• 2 other identifiers: MuciLight-19032020-A00976-33
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Oropharyngeal Cancer; Oral Cancer

Keywords

Oral cancer; Radiotherapy; Radio-chemotherapy; Mucositis; LED photobiomodulation (PLED); Oropharyngeal cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Pain related to the mucositis

  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)

  Through study completion, an average of 7 weeks

• Quality of Life (QoL)

  At baseline and at week 7 (end of the study)

• Modification of treatment by radiotherapy or radio-chemotherapy

  Through study completion, an average of 7 weeks

• Interruption of sessions

  Through study completion, an average of 7 weeks

Interventions

LED photobiomodulation PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Radiotherapy treatment completed
• Stage 3 or higher mucositis already installed
• History of skin porphyria or lupus erythematosus
• Enteral nutrition support in progress
• Pregnant or breast-feeding woman
• Patient under guardianship or curatorship

Sponsors & Collaborators

• Centre Oscar Lambret: lead
• Fondation Apicil: collaborator
• Santelys Association: collaborator

Study Sites (1)

Centre Oscar Lambret

Lille, 59020, France

Location

MeSH Terms

Conditions

Mouth Neoplasms; Oropharyngeal Neoplasms; Mucositis

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Xavier XL LIEM, MD

  Centre Oscar Lambret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: February 5, 2020
• Study Start: March 19, 2021
• Primary Completion: September 19, 2022
• Study Completion: September 19, 2022
• Last Updated: March 18, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)