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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.

Phase 3
18 Years
75 Years
Open (Enrolling)
Oral Squamous Cell Carcinoma, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx, Oral Mucositis

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Trial Information

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.

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.


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

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).

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).

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

To evaluate the efficacy of preventive and curative low energy laser induced mucositis in patients receiving concomitant chemotherapy and radiotherapy for squamous cell carcinoma of the head and neck with stage III-IV

Outcome Time Frame:

7 weeks

Safety Issue:


Principal Investigator


Investigator Role:

Principal Investigator

Investigator Affiliation:

Institut de Cancerologie de l'Ouest - Paul Papin


France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:




Start Date:

October 2008

Completion Date:

Related Keywords:

  • Oral Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of Oropharynx
  • Squamous Cell Carcinoma of Hypopharynx
  • Oral Mucositis
  • Head and neck cancer
  • Low level laser therapy
  • Mucositis induced by radiochemotherpy
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms
  • Stomatitis
  • Hypopharyngeal Neoplasms
  • Mucositis
  • Oropharyngeal Neoplasms