Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients
Role of SAMITAL® in Prevention and Treatment of Oral Mucositis in Patients Treated With Chemo-radiation (CT/RT)for Head-and-neck Squamous Cell Carcinomas. A Double-blind, Phase 2 Placebo Controlled, Randomized Trial.
The purpose of this study is to:
evaluate the activity of SAMITAL in reducing the incidence of severe mucositis in head-and-neck cancer patients undergoing chemo-radiotherapy.
assess tolerability of SAMITAL and the impact on patients reported outcomes.
Inclusion Criteria: Histologically proven squamous cell carcinomas of the head-and-neck Eligible primary tumor sites: oral cavity, oropharynx, larynx, hypopharynx Stage III or IV disease without evidence of distant metastases Patients candidate to definitive concurrent chemo-radiotherapy or induction chemotherapy followed by chemo-radiotherapy Age ≥ 18 years Karnofsky Performance Status ≥70 Life expectancy ≥6 months Able to swallow and retain oral medication Good state of dentition Patients must be available for treatment and follow-up Confirmation of adequate contraception use by the patient and/or partner Signed informed consent Exclusion Criteria: Previous radiotherapy of the oral cavity, and/or oropharynx, larynx, hypopharynx Serious co-morbidities: uncontrolled heart disease, heart failure within 6 months prior to study participation, history of serious neurological and/or psychiatric abnormalities. Chronic administration of steroids or immunosuppressants Pregnancy.