Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer (LaserMucite)
Oral Squamous Cell Carcinoma, Squamous Cell Carcinoma of Oropharynx, Squamous Cell Carcinoma of Hypopharynx
About this trial
This is an interventional treatment trial for Oral Squamous Cell Carcinoma focused on measuring Head and neck cancer, Low level laser therapy, Mucositis induced by radiochemotherpy
Eligibility Criteria
Inclusion Criteria:
- 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
- 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.
Exclusion Criteria:
- 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).
Sites / Locations
- Institut de Cancerologie de l'Ouest Paul Papin
- Centre Guillaume le Conquérant
- Hôpital La Pitié Salpêtrière
- Centre hospitalier universitaire La Milétrie
- Centre Jean Godinot
- Clinique Armoricaine de Radiologie
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
laser low-level energy functional
laser low-level energy nonfunctional
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.
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.