Health Condition 1: null- Head and neck cancer patients
Conditions
Interventions
Intervention1: Phlogam: Antiinflammatory enzymes
Each tablet contains
Trypsin 48mg
Bromelaine 90mg
Rutoside trihydrate 100mg
Total proteolytic activity not less than 1095 FIP Units/Tablet
Each tablet
Sponsors
Manipal University Postgraduate grant
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the efficacy of systemic enzyme therapy in reducing oral mucositis in head and neck cancer patients during radiotherapyTimepoint: Radiation Therapy Oncology Oral Mucositis Grading System will be used on the patients. Baseline followed by weekly analysis will be done for the 6 weeks duration of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine if patients receiving systemic enzyme therapy experience fewer complications associated with radiotherapyTimepoint: Common Terminology Criteria for Adverse Events Version 4.02 | — |
Countries
India
Contacts
Public ContactSanjay Hadigal
Kasturba Medical College, Mangalore
Outcome results
None listed