Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis. (MuciLight)
Primary Purpose
Oral Cancer, Oropharyngeal Cancer
Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
LED photobiomodulation
Sponsored by
About this trial
This is an interventional supportive care trial for Oral Cancer focused on measuring Oral cancer, Radiotherapy, Radio-chemotherapy, Mucositis, LED photobiomodulation (PLED), Oropharyngeal cancer
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
Sites / Locations
- Centre Oscar Lambret
Outcomes
Primary Outcome Measures
Mucositis assessment
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
Pain related to the mucositis
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.
Starting a level 3 analgesic treatment (morphine, oxycodone, fentanyl, hydromorphone)
Percentage of patients starting a level 3 analgesic treatment during the study.
Quality of Life (QoL)
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.
Modification of treatment by radiotherapy or radio-chemotherapy
Percentage of patient with an interruption (temporary or permanent) or dose modification.
Interruption of sessions
Percentage of patient with session interruption, temporary or permanent.
Number of side effects
Percentage of patients with side effect probably related to the photobiomodulation LED treatment.
Nutritional support by nasogastric tube or gastrostomy tube
Percentage of patients with needs of nutritional support by nasogastric tube or gastrostomy tube.
Weight variation
Weighting at each visit and comparison between the values
Performance status
Assessment of the general condition by the scale of performance status (OMS) from 0 to 5.
Full Information
NCT ID
NCT04251949
First Posted
January 3, 2020
Last Updated
December 5, 2022
Sponsor
Centre Oscar Lambret
Collaborators
Fondation Apicil, Santelys Association
1. Study Identification
Unique Protocol Identification Number
NCT04251949
Brief Title
Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis.
Acronym
MuciLight
Official Title
Evaluation of Photobiomodumation Using LED Lamp as a Curative Treatment for Oral or Oropharyngeal Mucositic Inducted by Radiation Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
March 19, 2021 (Actual)
Primary Completion Date
September 19, 2022 (Actual)
Study Completion Date
September 19, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Oscar Lambret
Collaborators
Fondation Apicil, Santelys Association
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Cancer, Oropharyngeal Cancer
Keywords
Oral cancer, Radiotherapy, Radio-chemotherapy, Mucositis, LED photobiomodulation (PLED), Oropharyngeal cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
LED photobiomodulation
Intervention Description
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 Measure Information:
Title
Mucositis assessment
Description
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.
Time Frame
Change from baseline mucositis assessment at 7 weeks
Secondary Outcome Measure Information:
Title
Pain related to the mucositis
Description
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.
Time Frame
At baseline, during each session - at least 3 times a week during 7 weeks, at the end of the study (week 7)
Title
Starting a level 3 analgesic treatment (morphine, oxycodone, fentanyl, hydromorphone)
Description
Percentage of patients starting a level 3 analgesic treatment during the study.
Time Frame
Through study completion, an average of 7 weeks
Title
Quality of Life (QoL)
Description
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.
Time Frame
At baseline and at week 7 (end of the study)
Title
Modification of treatment by radiotherapy or radio-chemotherapy
Description
Percentage of patient with an interruption (temporary or permanent) or dose modification.
Time Frame
Through study completion, an average of 7 weeks
Title
Interruption of sessions
Description
Percentage of patient with session interruption, temporary or permanent.
Time Frame
Through study completion, an average of 7 weeks
Title
Number of side effects
Description
Percentage of patients with side effect probably related to the photobiomodulation LED treatment.
Time Frame
Through study completion, an average of 7 weeks
Title
Nutritional support by nasogastric tube or gastrostomy tube
Description
Percentage of patients with needs of nutritional support by nasogastric tube or gastrostomy tube.
Time Frame
Through study completion, an average of 7 weeks
Title
Weight variation
Description
Weighting at each visit and comparison between the values
Time Frame
Every week during the study (7 weeks)
Title
Performance status
Description
Assessment of the general condition by the scale of performance status (OMS) from 0 to 5.
Time Frame
Every week during the study (7 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier XL LIEM, MD
Organizational Affiliation
Centre Oscar Lambret
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Oscar Lambret
City
Lille
ZIP/Postal Code
59020
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis.
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