Clinical trial NCT04251949: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Oral Cancer
Oropharyngeal Cancer
Keywords: Oral cancer
Radiotherapy
Radio-chemotherapy
Mucositis
LED photobiomodulation (PLED)
Oropharyngeal cancer
Lead sponsor: Centre Oscar Lambret
Sponsor class: OTHER
Collaborators: name: Fondation Apicil
name: Santelys Association
First posted: 2020-02-05
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Mucositis assessment
timeFrame: Change from baseline mucositis assessment at 7 weeks
Secondary outcomes:
measure: Pain related to the mucositis
timeFrame: At baseline, during each session - at least 3 times a week during 7 weeks, at the end of the study (week 7)
measure: Starting a level 3 analgesic treatment (morphine, oxycodone, fentanyl, hydromorphone)
timeFrame: Through study completion, an average of 7 weeks
measure: Quality of Life (QoL)
timeFrame: At baseline and at week 7 (end of the study)
measure: Modification of treatment by radiotherapy or radio-chemotherapy
timeFrame: Through study completion, an average of 7 weeks
measure: Interruption of sessions
timeFrame: Through study completion, an average of 7 weeks
measure: Number of side effects
timeFrame: Through study completion, an average of 7 weeks
measure: Nutritional support by nasogastric tube or gastrostomy tube
timeFrame: Through study completion, an average of 7 weeks
measure: Weight variation
timeFrame: Every week during the study (7 weeks)
measure: Performance status
timeFrame: Every week during the study (7 weeks)
Other outcomes:
Locations:
city: Lille
country: France
facility: Centre Oscar Lambret
Study officials:
affiliation: Centre Oscar Lambret
name: Xavier XL LIEM, MD
role: PRINCIPAL_INVESTIGATOR
References: