Evaluation of dexamethasone solution efficacy on prevention of radiotherapy induced mucositis in patients with head and neck cancer
Phase 2
- Conditions
- Radiotherapy-induced mucositis in head and neck patients.Oral mucositis (ulcerative) due to radiationK12.33
- Registration Number
- IRCT20240525061893N1
- Lead Sponsor
- Shiraz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Performance level of KPS=70 (or ECOG score=0-1)
Newly diagnosed patient
Having a pathological diagnosis of head and neck cancer
Presence of adjuvant or definitive radiotherapy indication
The treatment dose is at least 60 Gry
Placement of at least half of the oral cavity in the radiotherapy treatment field
Exclusion Criteria
Lack of consent to participate in the study
Presence of chronic kidney (eGFR <50 ml/min), heart (EF <50%) and liver diseases (liver enzyme levels > three times normal)
History of previous malignancy
History of previous radiation therapy in the head and neck area
History of hypersensitivity reaction to dexamethasone mouthwash
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method