Role of SAMITAL® in the Relief of Chemo-radiation (CT-RT) Induced Oral Mucositis in Head and Neck Cancer Patients
Conditions
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
Interventional
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
Intervention
Name: SAMITAL® Type: Drug
Name: Placebo sachets Type: Drug
Overall Status
Recruiting
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.
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.
Location
Radiotherapy Department, Istituto Oncologico Veneto
Padova, Italy
Status: Recruiting
Start Date
December 2012
Completion Date
December 2016
Sponsors
Istituto Oncologico Veneto IRCCS
Source
Istituto Oncologico Veneto IRCCS
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page