Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis.
NCT ID: NCT04251949
Last Updated: 2022-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2021-03-19
2022-09-19
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Fondation Apicil
OTHER
Santelys Association
OTHER
Centre Oscar Lambret
OTHER
Responsible Party
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Principal Investigators
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Xavier XL LIEM, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Oscar Lambret
Locations
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Centre Oscar Lambret
Lille, , France
Countries
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Other Identifiers
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2020-A00976-33
Identifier Type: OTHER
Identifier Source: secondary_id
MuciLight-1903
Identifier Type: -
Identifier Source: org_study_id
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