Oral CancerPhase 2MuciLightNCT04251949
Evaluation of the Photobiomodulation Using LED Lamp for Curative Treatment of Radio-induced Mucositis.
A Phase 2 study testing LED photobiomodulation in people with Oral Cancer and Oropharyngeal Cancer, run by Centre Oscar Lambret at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Oral Cancer, Oropharyngeal Cancer
- What is being tested?
- LED photobiomodulation
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- 1 siteFrance
- Study dates
- 19 Mar 2021to 19 Sep 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Photobiomodumation Using LED Lamp as a Curative Treatment for Oral or Oropharyngeal Mucositic Inducted by Radiation Therapy
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.
Read the 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.
- Conditions
- Oral Cancer, Oropharyngeal Cancer
- Being tested
- LED photobiomodulation
- Keywords
- Oral cancer, Radiotherapy, Radio-chemotherapy, Mucositis, LED photobiomodulation (PLED), Oropharyngeal cancer
- Medical subject headings
- Mouth Neoplasms, Oropharyngeal Neoplasms, Mucositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LED photobiomodulationProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline mucositis assessment at 7 weeks
Secondary outcomes (9)
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.
Measured: At baseline, during each session - at least 3 times a week during 7 weeks, at the end of the study (week 7)
Starting a level 3 analgesic treatment (morphine, oxycodone, fentanyl, hydromorphone)
Percentage of patients starting a level 3 analgesic treatment during the study.
Measured: Through study completion, an average of 7 weeks
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.
Measured: At baseline and at week 7 (end of the study)
Modification of treatment by radiotherapy or radio-chemotherapy
Percentage of patient with an interruption (temporary or permanent) or dose modification.
Measured: Through study completion, an average of 7 weeks
Interruption of sessions
Percentage of patient with session interruption, temporary or permanent.
Measured: Through study completion, an average of 7 weeks
Number of side effects
Percentage of patients with side effect probably related to the photobiomodulation LED treatment.
Measured: Through study completion, an average of 7 weeks
Nutritional support by nasogastric tube or gastrostomy tube
Percentage of patients with needs of nutritional support by nasogastric tube or gastrostomy tube.
Measured: Through study completion, an average of 7 weeks
Weight variation
Weighting at each visit and comparison between the values
Measured: Every week during the study (7 weeks)
Performance status
Assessment of the general condition by the scale of performance status (OMS) from 0 to 5.
Measured: Every week during the study (7 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2020
- Study start19 Mar 2021
- Primary completion19 Sep 2022
- Study completion19 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Oscar Lambret
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Apicil, Santelys Association
- Responsible party
- Sponsor
- Investigators
- Xavier XL LIEM, MD, Principal investigator, Centre Oscar Lambret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04251949
- Sponsor's protocol ID
- MuciLight-1903
- Other IDs
- 2020-A00976-33
- Acronym
- MuciLight
- Status last verified
- Mar 2026
- First submitted
- 3 Jan 2020
- Last updated
- 18 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Photobiomodumation Using LED Lamp as a Curative Treatment for Oral or Oropharyngeal Mucositic Inducted by Radiation Therapy
- ClinicalTrials.gov ID
- NCT04251949
- Acronym / sponsor ID
- MuciLight / MuciLight-1903
- Conditions
- Oral Cancer, Oropharyngeal Cancer
- Keywords
- Oral cancer, Radiotherapy, Radio-chemotherapy, Mucositis, LED photobiomodulation (PLED), Oropharyngeal cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Centre Oscar LambretUniversity, hospital or other
- Collaborators
- Fondation Apicil, Santelys Association
- Study start
- 19 Mar 2021 (actual)
- Primary completion
- 19 Sep 2022 (actual)
- Study completion
- 19 Sep 2022 (actual)
- First posted
- 5 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LED photobiomodulation1 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. | Procedure or surgery | – |
Primary outcome
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.
9 secondary outcomes
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)
Starting a level 3 analgesic treatment (morphine, oxycodone, fentanyl, hydromorphone)
Time frame: Through study completion, an average of 7 weeks
Quality of Life (QoL)
Time frame: At baseline and at week 7 (end of the study)
Modification of treatment by radiotherapy or radio-chemotherapy
Time frame: Through study completion, an average of 7 weeks
Interruption of sessions
Time frame: Through study completion, an average of 7 weeks
Number of side effects
Time frame: Through study completion, an average of 7 weeks
Nutritional support by nasogastric tube or gastrostomy tube
Time frame: Through study completion, an average of 7 weeks
Weight variation
Time frame: Every week during the study (7 weeks)
Performance status
Time frame: Every week during the study (7 weeks)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier XL LIEM, MD principal investigator
Centre Oscar Lambret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LED photobiomodulation in people with Oral Cancer and Oropharyngeal Cancer, run by Centre Oscar Lambret at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mucositis assessment (time frame: Change from baseline mucositis assessment at 7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2026.