Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients

• Status: Completed
• Trial end date: 2018-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Oncologico Veneto IRCCS
• Collaborator: Indena S.p.A

Criteria

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.