A clinical trial to improve the immune status of treated head and neck cancer patients and to prevent recurrence.
Phase 3
Completed
- Conditions
- Health Condition 1: null- Head and neck cancers treated with radical radiotherapy and are in complete remission
- Registration Number
- CTRI/2012/05/002667
- Lead Sponsor
- Kerala State Council for Science Technology and Environment
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 100
Inclusion Criteria
Subjects aged 25 â?? 70 years with head and neck cancers, in complete remission on two consecutive visits after the completion of radical radiotherapy ± chemotherapy will be eligible
Exclusion Criteria
Patients with any one or more of the following condition,
•Hypertension and Diabetes
•Performance status 3 or more
•Serum cholesterol above 250mg%
•History of liver disease (hepatitis, cirrhosis liver)
•History of ischemic heart disease including angina
•Kidney disease (urine albumin +, blood urea above 50mg%)
•Mental illness
•Pregnant women
•Unwillingness to participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method a)Loco - regional recurrence <br/ ><br>b)Second primary tumours <br/ ><br>Timepoint: Locoregional recurrence and occurrence of second primary tumours after 2 years of recruitment.
- Secondary Outcome Measures
Name Time Method Changes in the level of markers of immune systemTimepoint: Change in the level of immune markers from baseline and after 1 year of administration of compound