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NCT Number: NCT04251949

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

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.

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Key information

Conditions

Oral Cancer Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Head and Neck Neoplasms Mouth Diseases Mouth Neoplasms Mucositis Neoplasms Neoplasms by Site Oropharyngeal Cancer Oropharyngeal Neoplasms Otorhinolaryngologic Diseases Otorhinolaryngologic Neoplasms Pharyngeal Diseases Pharyngeal Neoplasms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Oscar Lambret

Lille, 59020, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. Interruption of sessions

    Time frame: Through study completion, an average of 7 weeks

    Percentage of patient with session interruption, temporary or permanent.

  6. 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.

  7. 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.

  8. Weight variation

    Time frame: Every week during the study (7 weeks)

    Weighting at each visit and comparison between the values

  9. 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.

Sponsors and collaborators

Lead sponsor

Centre Oscar Lambret

Other

Collaborators

  • Fondation Apicil
  • Santelys Association

Registry information

Official study title

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

Acronym: MuciLight

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 5, 2020
Registry last updated
Mar 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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