Role of enzyme therapy in treating oral ulcers caused by radiotherapy
Phase 4
- Conditions
- Health Condition 1: null- Head and neck cancer patients
- Registration Number
- CTRI/2013/04/003569
- Lead Sponsor
- Manipal University Postgraduate grant
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 34
Inclusion Criteria
1. Male and female adult subjects, ages, 18-65 years, inclusive
2. Diagnosis of head and neck cancer whose primary mode of treatment is radiation
3. The scheduled dose of radiation should be between 180Cgy to 200Cgy per day, five time a week
4. Willing and able to give written informed consent
5. Karnofsky Performance Status (KPS) >60
Exclusion Criteria
1. Current evidence or history of any clinically significant acute or unstable comorbid conditions
2. History of current, clinically significant mental disorder- or an antagonistic personality that compromises the validity of informed consent
3. History of allergy or sensitivity to drugs
4. Subjects who are pregnant, lactating, breast feeding or planning to conceive
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method