Radiation Oncology volume 14 , Article number: 83 Cite this article. Metrics details. Among 97 randomised patients, 83 patients Oral mucositis OM is one of the most common adverse effects of chemotherapy and radiotherapy, especially for head and neck cancer HNC. Prevalence of iatrogenic mucosal lesions depends on patient characteristics risk factors and treatments, particularly with more aggressive approaches: chemotherapy in addition of radiotherapy, or targeted agents as cetuximab during radiation regimen [ 1 , 2 ].
Several prospective studies specify that all patients reduce their quality of life QoL due to oral pain and mucositis; they report these side effects as the most troublesome. Moreover unplanned radiation treatment breaks lead to lower outcomes in terms of local control rates [ 6 ]. Origin and pathobiology of mucosal damage are still unclear, whereas this side effect is a significant problem for patients and oncologists. Patients included were randomised in a placebo or active treatment arm of lasertherapy.
Treatment allocation was centralised, thus randomisation was performed according a ratio and stratified by centre. To be enrolled, they should exhibit a locally advanced histologically proven squamous cell carcinoma of oral cavity, oropharynx or hypopharynx stage III or IV. Subjects had a scheduled CRT without or after surgery , with platinum salts with or without 5-FU or cetuximab alone. The exclusion criteria were neo-adjuvant chemotherapy; distant metastasis; previous malignancy over the last 5 years except basal cell carcinoma or carcinoma in situ of the uterine cervix ; previous radiotherapy in the head and neck region; severe allergy to platinum salts; any uncontrolled comorbidity pulmonary, kidney, liver, or heart failure ; pregnancy or breastfeeding.
Every patient was randomly assigned to active laser group group A or control group with placebo group B. All the patients received same instructions about oral hygiene and abstinence from tobacco and alcohol. Protective eyeglasses were used to avoid detrimental effects of the laser beam on eyes, and thus blind procedure was respected.
The differences during laser session were laser-on or laser-off condition and time applications, known to the physician, not to the patient. The Table 1 summarises lasertherapy parameters. Dose was prescribed according to the surgical option: adjuvant or exclusive CRT and constraints for critical normal tissue structures were respected.
