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NCT01772706 · REGISTRY CONDITION SEARCH

Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2026-07-01

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Patients With Oral Mucositis Grade ≥2 Assessed by World Health Organization (WHO) Classification

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outcome · POSTED

Number of Patients by Pain Intensity Category at Final Treatment Session With Numeric Rating Scale (NRS)

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: 1. Age between 18 and 75 years 2. Patient with squamous cell carcinoma of the oral cavity, oropharynx or hypopharynx, stage III-IV, histologically confirmed 3. PS \> or = 2 4. Estimated life expectancy greater than 3 months in the absence of treatment 5. Concomitant chemotherapy with one of the following choices not prohibited: * Cetuximab alone * 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 6. 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. 7. For women of childbearing potential, a reliable contraceptive measure (hormonal contraception, intrauterine device) is required. Exclusion Criteria: 1. Presence of other malignancies either concomitant or diagnosed within the last five years, except basal cell carcinoma or in situ carcinoma of the cervix 2. Neoadjuvant chemotherapy 3. Metastatic disease 4. Previous treatment with ENT radiotherapy 5. Severe hypersensitivity known to platinum based agent 6. Any uncontrolled pathology (respiratory, cardiac, hepatic or renal) 7. Pregnant or breastfeeding women (a seric or urinary pregnancy test must be negative at the time of study entry for women of childbearing age).
healthy Volunteers
false
maximum Age
75 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    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.
    label
    laser low-level energy functional
    type
    EXPERIMENTAL
  2. description
    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.
    label
    laser low-level energy nonfunctional
    type
    PLACEBO_COMPARATOR
interventions
  1. name
    low level laser therapy
    type
    PROCEDURE
  2. name
    placebo (laser low level energy nonfunctional)
    type
    PROCEDURE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
TRIPLE
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
  3. OUTCOMES_ASSESSOR
primary Purpose
TREATMENT
Enrollment
count
97
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    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
secondary Outcomes
  1. description
    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).
    measure
    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.
Full study description
brief 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.
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).
Source references
references
  1. citation
    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.
    pmid
    31118057
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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        exact text
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      offset unit
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      query cond
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      query disease state id
      ds-hypopharyngeal-cancer
      source file
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    Preserved source evidence · Not medical advice