SIlymarin vs BEnzydamine in Radiation-Induced orophAryngeal mucositis
Phase 3
- Conditions
- Malignant neoplasm of head, face and neck.Malignant neoplasm of head, face and neckC76.0
- Registration Number
- IRCT20211202053252N2
- Lead Sponsor
- Babol University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 98
Inclusion Criteria
Age over 18 years old
Any ECOG performance status
Head and neck cancer patient
Any setting of radiation (i.e. definitive, neoadjuvant, adjuvant)
Receiving at least 50 Gy radiation to 2 out of 4 subsite of the head and neck, including oral cavity, Oropharynx, hypopharynx, and the larynx
More than 2 cm of irradiated mucosal surface in any head and neck subsite
Exclusion Criteria
History of severe allergy to silymarin, benzydamine or other NSAIDs
Narcotic use in the last month (even once)
History of radiation therapy to the same target areas
Presence of mucositis on admission
History of dry mouth
Proven dementia or history of uncontrolled psychiatric disease
Pregnancy
Malnutrition
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method