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

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Brief Title

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

Official Title

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

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.
    

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 Phase

Phase 2

Study Type

Interventional


Primary Outcome

Mucositis assessment

Secondary Outcome

 Pain related to the mucositis

Condition

Oral Cancer

Intervention

LED photobiomodulation


Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

30

Start Date

September 2020

Completion Date

August 2021

Primary Completion Date

June 2021

Eligibility 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
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Xavier XL LIEM, MD, 0320295935, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04251949

Organization ID

MuciLight-1903

Secondary IDs

2020-A00976-33

Responsible Party

Sponsor

Study Sponsor

Centre Oscar Lambret

Collaborators

 Fondation Apicil

Study Sponsor

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


Verification Date

May 2020