Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients
Head-and-neck Squamous Cell Carcinoma - Oral Mucositis.
Conditions: official terms
Carcinoma - Carcinoma, Squamous Cell - Head and Neck Neoplasms - Mucositis - Stomatitis
Conditions: Keywords
head and neck, Squamous Cell Carcinoma, oral mucositis, Chemo-radiotherapy
Study Type
Study Phase
Phase 2
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Name: SAMITAL® Type: Drug
Name: Placebo sachets Type: Drug
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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.
Radiotherapy Department, Istituto Oncologico Veneto
Padova, Italy
Status: Recruiting
Start Date
December 2012
Completion Date
December 2016
Istituto Oncologico Veneto IRCCS
Istituto Oncologico Veneto IRCCS
Record processing date processed this data on July 28, 2015 page