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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04251949
Recruitment Status : Not yet recruiting
First Posted : February 5, 2020
Last Update Posted : May 28, 2020
Sponsor:
Collaborators:
Fondation Apicil
Santélys
Information provided by (Responsible Party):
Centre Oscar Lambret

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.

Condition or disease Intervention/treatment Phase
Oral Cancer Oropharyngeal Cancer Procedure: LED photobiomodulation Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Photobiomodumation Using LED Lamp as a Curative Treatment for Oral or Oropharyngeal Mucositic Inducted by Radiation Therapy
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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.


Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04251949


Contacts
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Contact: Marie MV VANSEYMORTIER 0320295935 promotion@o-lambret.fr

Locations
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France
Centre Oscar Lambret
Lille, France, 59020
Contact: Marie MV VANSEYMORTIER    0320295935    promotion@o-lambret.fr   
Contact: Xavier XL LIEM, MD    0320295935    promotion@o-lambret.fr   
Principal Investigator: Xavier XL LIEM, MD         
Sub-Investigator: Geoffrey GM MARTINAGE, MD         
Sub-Investigator: Xavier XM MIRABEL, MD         
Sub-Investigator: David DP PASQUIER, MD         
Sponsors and Collaborators
Centre Oscar Lambret
Fondation Apicil
Santélys
Investigators
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Principal Investigator: Xavier XL LIEM, MD Centre Oscar Lambret
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Responsible Party: Centre Oscar Lambret
ClinicalTrials.gov Identifier: NCT04251949    
Other Study ID Numbers: MuciLight-1903
2020-A00976-33 ( Other Identifier: ANSM )
First Posted: February 5, 2020    Key Record Dates
Last Update Posted: May 28, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Oscar Lambret:
Oral cancer
Radiotherapy
Radio-chemotherapy
Mucositis
LED photobiomodulation (PLED)
Oropharyngeal cancer
Additional relevant MeSH terms:
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Oropharyngeal Neoplasms
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Neoplasms
Pharyngeal Diseases
Otorhinolaryngologic Diseases