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

December 5, 2022 updated by: Centre Oscar Lambret

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lille, France, 59020
        • Centre Oscar Lambret

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mucositis assessment
Time Frame: Change from baseline mucositis assessment at 7 weeks

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
Time Frame: At baseline, during each session - at least 3 times a week during 7 weeks, at the end of the study (week 7)

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)
Time Frame: Through study completion, an average of 7 weeks
Percentage of patients starting a level 3 analgesic treatment during the study.
Through study completion, an average of 7 weeks
Quality of Life (QoL)
Time Frame: At baseline and at week 7 (end of 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.
At baseline and at week 7 (end of the study)
Modification of treatment by radiotherapy or radio-chemotherapy
Time Frame: Through study completion, an average of 7 weeks
Percentage of patient with an interruption (temporary or permanent) or dose modification.
Through study completion, an average of 7 weeks
Interruption of sessions
Time Frame: Through study completion, an average of 7 weeks
Percentage of patient with session interruption, temporary or permanent.
Through study completion, an average of 7 weeks
Number of side effects
Time Frame: Through study completion, an average of 7 weeks
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
Time Frame: Through study completion, an average of 7 weeks
Percentage of patients with needs of nutritional support by nasogastric tube or gastrostomy tube.
Through study completion, an average of 7 weeks
Weight variation
Time Frame: Every week during the study (7 weeks)
Weighting at each visit and comparison between the values
Every week during the study (7 weeks)
Performance status
Time Frame: Every week during the study (7 weeks)
Assessment of the general condition by the scale of performance status (OMS) from 0 to 5.
Every week during the study (7 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Oscar Lambret

Collaborators

Fondation Apicil
Santelys Association

Investigators

  • Principal Investigator: Xavier XL LIEM, MD, Centre Oscar Lambret

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 19, 2021

Primary Completion (Actual)

September 19, 2022

Study Completion (Actual)

September 19, 2022

Study Registration Dates

First Submitted

January 3, 2020

First Submitted That Met QC Criteria

January 30, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Estimate)

December 6, 2022

Last Update Submitted That Met QC Criteria

December 5, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MuciLight-1903
  • 2020-A00976-33 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Oral Cancer

Clinical Trials on LED photobiomodulation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Hungary

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe