Oral Squamous Cell CarcinomaLaserMuciteNCT01772706
Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer
A study testing low level laser therapy in people with Oral Squamous Cell Carcinoma and Squamous Cell Carcinoma of Oropharynx, run by Institut Cancerologie de l'Ouest at 6 sites in France.
Trial summary
The purpose of the study is to assess in a randomized, double blind, controlled, multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and neck carcinomas. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oral Squamous Cell Carcinoma, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx
- What is being tested?
- low level laser therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 97 participants
- Where
- 6 sitesFrance
- Study dates
- 30 Oct 2008to Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 75 years
- Patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage III-IV, histologically confirmed
- PS > or = 2
- Estimated life expectancy greater than 3 months in the absence of treatment
- Concomitant chemotherapy with one of the following choices not prohibited:
- Cetuximab alone
Show all 15Show fewer
- 5-FU combined to Carboplatin or Cisplatin
- Cisplatin alone Being defined as follows: serum creatinine < 150 µmol/l and creatinine clearance superior or equal to 55ml/min (calculated with the Cockcroft method) in case of serum creatinine > 120 µmol/l
- Appropriate hematological, renal and hepatic function parameters, within 15 days prior to randomization, with the following results:
- Hemoglobin> 8g/dL
- Neutrophils> 1500 x 109 / L
- Platelets> 100 x 109 / l
- Total bilirubin <1.5 times the upper limit of normal
- ALT / AST and alkaline phosphatase <2.5 times the upper limit of normal.
- For women of childbearing potential, a reliable contraceptive measure (hormonal contraception, intrauterine device) is required.
Who cannot join
- Presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix
- Neoadjuvant chemotherapy
- Metastatic disease
- Previous treatment with ENT radiotherapy
- Severe hypersensitivity known to platinum based agent
- Any uncontrolled pathology (respiratory, cardiac, hepatic or renal)
- Pregnant or breastfeeding women (a seric or urinary pregnancy test must be negative at the time of study entry for women of childbearing age).
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Institut de Cancerologie de l'Ouest Paul Papin
Angers, 49933
Centre Guillaume le Conquérant
Le Havre, 76600
Hôpital La Pitié Salpêtrière
Paris, 75013
Centre hospitalier universitaire La Milétrie
Poitiers, 86021
Centre Jean Godinot
Reims, 51100
Clinique Armoricaine de Radiologie
Saint-Brieuc, 22015
About this study
Official title: A Randomized, Double Blind, Controlled, Multi-center, Phase III Study to Assess Efficacy of Low Level Diode Laser (100 MW, 658 Nm), in the Prevention and Treatment of Radiochemotherapy-induced Mucositis in Head and Neck Cancer.
The purpose of the study is to assess in a randomized, double blind, controlled, multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and neck carcinomas.
Read the detailed description
This is a Phase III randomized, double-blind, multicenter study, with two groups of patients receiving radiotherapy and concomitant chemotherapy.
The patients will be randomized as follows: Arm A = patients will receive a preventive and curative treatment by low-energy laser, and arm B = a control group treated with standard local treatments and a placebo laser (laser nonfunctional).
Randomization will be balanced in a ratio 1: 1 and stratified by the investigator site. Assessments of mucositis, nutritional status, tolerance of the laser and pain will be performed throughout the treatment, once a week, by an investigator unaware of the patients treatment arm. The locoregional control will be evaluated every 3 months during the first year, then every 6 months up to 5 years. In case of progression, treatments undertaken and their results should be reported.
Radiotherapy: All patients will be treated with conformal radiotherapy with or without IMRT. The dose should be adapted to the treatment indication (exclusive or postoperative) and the histological findings in case of tumoral resection.
The radiotherapy will be prescribed in accordance with the recommendations of the ICRU 50 report. The dose delivered will always be 2 Gy per day 5 times a week. All beams will be treated in each session. A radiological audit will be conducted for each beam treated by photons in the first session and at least once a week.
Chemotherapy:
Several chemotherapies concomitant to radiotherapy are possible:
- a combination of 5-FU and Cisplatin
- a combination of 5-FU and Carboplatin
- Cisplatin alone
- Cetuximab alone
Dental care: All patients (except edentulous) will be seen in odontostomatology consultation prior to the treatment for dental care if necessary or potential production of fluorinated gutters During the treatment, all patients will receive oral care
The dosimetric study will concern the cross section, the frontal and sagittal planes through the axis of the lateral beams.
Arm A : laser low-level energy functional The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grades superior or equal to 2 stomatitis injuries. The application is painless, athermal, odorless and completely silent. The patient will wear glasses for retinal protection. The operator will also wear glasses for his protection but allowing nevertheless the view of the beams and its limits.
The tumor areas macroscopically invaded will be excluded from the areas application.
The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by a corresponding abacus : [t(s) = energy (J/cm2) x surface (cm2) / puissance (W)]. The overall duration will be a few minutes varying depending on the surface to be treated The usual dental care will be prescribed when required.
Arm B : laser low-level energy nonfunctional The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute. All applications will be performed by one single operator by center. The results will be assessed once a week by another physician (or nurse specifically trained) in each center, unaware of whether the patients had laser sessions or not, in order to respect the "blinding". The assessment will be detailed on a specifique sheet, specifying the degree of mucositis (WHO), the level of pain, body weight , type of feeding , any analgesic treatment taken by the patient, quality of life specific questionnaire, and the possible end of treatment or therapeutic modifications (number of cycles of chemotherapy, dosage).
The laser should be started as soon as a grade 2 mucositis (WHO) is observed and will be continued throughout the radio-chemotherapy until improvement of the mucositis (grade <2).
- Conditions
- Oral Squamous Cell Carcinoma, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx, Oral Mucositis
- Being tested
- low level laser therapy, placebo (laser low level energy nonfunctional)
- Keywords
- Head and neck cancer, Low level laser therapy, Mucositis induced by radiochemotherpy
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Stomatitis, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
low level laser therapyProcedure or surgery
placebo (laser low level energy nonfunctional)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| laser low-level energy functional | Experimental | The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus. |
| laser low-level energy nonfunctional | Placebo comparator | The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients With Oral Mucositis Grade ≥2 Assessed by World Health Organization (WHO) Classification
The primary outcome is the number of patients with oral mucositis grade ≥2 as assessed by the World Health Organization (WHO) oral mucositis grading scale, reflecting functional impairment in oral intake.
Oral mucositis is assessed weekly to evaluate the preventive and therapeutic efficacy of low-level laser therapy in patients undergoing concomitant radiotherapy and chemotherapy for stage III-IV head and neck squamous cell carcinoma.
Measured: Weekly assessments conducted over a 7-week period, from the initiation of concomitant chemoradiotherapy to the completion of treatment
Secondary outcomes (1)
Number of Patients by Pain Intensity Category at Final Treatment Session With Numeric Rating Scale (NRS)
Pain intensity is evaluated at the final treatment session using a Numeric Rating Scale (NRS) from 0 (no pain) to 10 (worst possible pain), with scores categorized as 0 (no pain), 1-3 (mild pain), 4-6 (moderate pain), and 7-10 (severe pain).
Measured: Assessment at Week 7, corresponding to the completion of concomitant chemoradiotherapy.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2013 (estimated)
- Study start30 Oct 2008
- Primary completionMar 2020
- Study completionMar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Squamous Cell CarcinomaStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Cancerologie de l'Ouest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric JADAUD, MD, Principal investigator, Institut de Cancerologie de l'Ouest - Paul Papin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01772706
- Sponsor's protocol ID
- CPP400
- Other IDs
- 2008-003681-26, 2008
- Acronym
- LaserMucite
- Status last verified
- Jun 2026
- First submitted
- 16 Jan 2013
- Last updated
- 1 Jul 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Legoute F, Bensadoun RJ, Seegers V, Pointreau Y, Caron D, Lang P, Prevost A, Martin L, Schick U, Morvant B, Capitain O, Calais G, Jadaud E. Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial. Radiat Oncol. 2019 May 22;14(1):83. doi: 10.1186/s13014-019-1292-2.
PubMed 31118057
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Controlled, Multi-center, Phase III Study to Assess Efficacy of Low Level Diode Laser (100 MW, 658 Nm), in the Prevention and Treatment of Radiochemotherapy-induced Mucositis in Head and Neck Cancer.
- ClinicalTrials.gov ID
- NCT01772706
- Acronym / sponsor ID
- LaserMucite / CPP400
- Conditions
- Oral Squamous Cell Carcinoma, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx, Oral Mucositis
- Keywords
- Head and neck cancer, Low level laser therapy, Mucositis induced by radiochemotherpy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Institut Cancerologie de l'OuestUniversity, hospital or other
- Study start
- 30 Oct 2008 (actual)
- Primary completion
- Mar 2020 (actual)
- Study completion
- Mar 2020 (actual)
- First posted
- 21 Jan 2013 (estimated)
- Results
- Posted 1 Jul 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to assess in a randomized, double blind, controlled, multi-center, phase III study, the efficacy of low level diode laser (100 MW, 658 Nm), in the prevention and treatment of radiochemotherapy-induced mucositis for stage III and IV head and neck carcinomas.
Detailed description
This is a Phase III randomized, double-blind, multicenter study, with two groups of patients receiving radiotherapy and concomitant chemotherapy.
The patients will be randomized as follows: Arm A = patients will receive a preventive and curative treatment by low-energy laser, and arm B = a control group treated with standard local treatments and a placebo laser (laser nonfunctional).
Randomization will be balanced in a ratio 1: 1 and stratified by the investigator site. Assessments of mucositis, nutritional status, tolerance of the laser and pain will be performed throughout the treatment, once a week, by an investigator unaware of the patients treatment arm. The locoregional control will be evaluated every 3 months during the first year, then every 6 months up to 5 years. In case of progression, treatments undertaken and their results should be reported.
Radiotherapy: All patients will be treated with conformal radiotherapy with or without IMRT. The dose should be adapted to the treatment indication (exclusive or postoperative) and the histological findings in case of tumoral resection.
The radiotherapy will be prescribed in accordance with the recommendations of the ICRU 50 report. The dose delivered will always be 2 Gy per day 5 times a week. All beams will be treated in each session. A radiological audit will be conducted for each beam treated by photons in the first session and at least once a week.
Chemotherapy:
Several chemotherapies concomitant to radiotherapy are possible:
- a combination of 5-FU and Cisplatin
- a combination of 5-FU and Carboplatin
- Cisplatin alone
- Cetuximab alone
Dental care: All patients (except edentulous) will be seen in odontostomatology consultation prior to the treatment for dental care if necessary or potential production of fluorinated gutters During the treatment, all patients will receive oral care
The dosimetric study will concern the cross section, the frontal and sagittal planes through the axis of the lateral beams.
Arm A : laser low-level energy functional The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grades superior or equal to 2 stomatitis injuries. The application is painless, athermal, odorless and completely silent. The patient will wear glasses for retinal protection. The operator will also wear glasses for his protection but allowing nevertheless the view of the beams and its limits.
The tumor areas macroscopically invaded will be excluded from the areas application.
The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by a corresponding abacus : [t(s) = energy (J/cm2) x surface (cm2) / puissance (W)]. The overall duration will be a few minutes varying depending on the surface to be treated The usual dental care will be prescribed when required.
Arm B : laser low-level energy nonfunctional The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute. All applications will be performed by one single operator by center. The results will be assessed once a week by another physician (or nurse specifically trained) in each center, unaware of whether the patients had laser sessions or not, in order to respect the "blinding". The assessment will be detailed on a specifique sheet, specifying the degree of mucositis (WHO), the level of pain, body weight , type of feeding , any analgesic treatment taken by the patient, quality of life specific questionnaire, and the possible end of treatment or therapeutic modifications (number of cycles of chemotherapy, dosage).
The laser should be started as soon as a grade 2 mucositis (WHO) is observed and will be continued throughout the radio-chemotherapy until improvement of the mucositis (grade <2).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laser low-level energy functional | Experimental | –The material used will be a diode laser of 100 mW, with a wavelength of 658 nm. Application will be made after each radiotherapy session in an adapted room (low light intensity, possibility of ENT examination) on all grade superior or equal to 2 stomatitis injuries. The energetic dose delivered will be 4 J/cm2. The duration of the treatment for one will be determined by an abacus. |
| laser low-level energy nonfunctional | Placebo comparator | –The procedure is identical to the one used in arm A but the laser will not be functional. The period of application will be around one minute. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Age between 18 and 75 years
- Patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage III-IV, histologically confirmed
- PS > or = 2
- Estimated life expectancy greater than 3 months in the absence of treatment
- Concomitant chemotherapy with one of the following choices not prohibited:
Key exclusion criteria (7 listed)
- Presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix
- Neoadjuvant chemotherapy
- Metastatic disease
- Previous treatment with ENT radiotherapy
- Severe hypersensitivity known to platinum based agent
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 |
|---|---|---|
| low level laser therapy | Procedure or surgery | – |
| placebo (laser low level energy nonfunctional) | Procedure or surgery | – |
Primary outcome
Number of Patients With Oral Mucositis Grade ≥2 Assessed by World Health Organization (WHO) Classification
Time frame: Weekly assessments conducted over a 7-week period, from the initiation of concomitant chemoradiotherapy to the completion of treatment
The primary outcome is the number of patients with oral mucositis grade ≥2 as assessed by the World Health Organization (WHO) oral mucositis grading scale, reflecting functional impairment in oral intake. Oral mucositis is assessed weekly to evaluate the preventive and therapeutic efficacy of low-level laser therapy in patients undergoing concomitant radiotherapy and chemotherapy for stage III-IV head and neck squamous cell carcinoma.
1 secondary outcome
Number of Patients by Pain Intensity Category at Final Treatment Session With Numeric Rating Scale (NRS)
Time frame: Assessment at Week 7, corresponding to the completion of concomitant chemoradiotherapy.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 31118057Legoute F, Bensadoun RJ, Seegers V, Pointreau Y, Caron D, Lang P, Prevost A, Martin L, Schick U, Morvant B, Capitain O, Calais G, Jadaud E. Low-level laser therapy in treatment of chemoradiotherapy-induced mucositis in head and neck cancer: results of a randomised, triple blind, multicentre phase III trial. Radiat Oncol. 2019 May 22;14(1):83. doi: 10.1186/s13014-019-1292-2.
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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.
Eric JADAUD, MD principal investigator
Institut de Cancerologie de l'Ouest - Paul Papin
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing low level laser therapy in people with Oral Squamous Cell Carcinoma and Squamous Cell Carcinoma of Oropharynx, run by Institut Cancerologie de l'Ouest at 6 sites 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 15 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 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jul 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Patients With Oral Mucositis Grade ≥2 Assessed by World Health Organization (WHO) Classification (time frame: Weekly assessments conducted over a 7-week period, from the initiation of concomitant chemoradiotherapy to the completion of treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01772706, which also lists 1 linked publication.
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 1 Jul 2026.