Phase II Trial of Curcumin in Advanced Head and Neck Cancer Treatment
- Registration Number
- CTRI/2008/091/000194
- Lead Sponsor
- DBT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
1. Patients with histo-pathological confirmed squamous cell carcinoma of head and neck (oral cavity/ pharynx/ larynx)
2. Patients who have advanced incurable cancer of head and neck region at the initial diagnosis or those who have failed all standard cancer specific treatment including chemotherapy, radiotherapy
3. Patient has signed and dated the informed consent document
4. Patient is willing and able to fully participate for the duration of the study
5. Patient with anticipated life of more than two months on clinical assessment by team members
1. Patient is less than 18 years of age
2. Patient is participating in any other study
3. Patient with non-squamous cell cancers
4. Patient who does not comply with assigned treatment protocol
5. Patient with potential behavior and cognitive impairment
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. To establish the chemotherapeutic role of Curcumin in advanced head and neck cancers<br><br>2. To establish supportive role (enhancement of quality of life) in advanced head and neck cancer<br><br>3. To establish the modulation of proven biomarkers in advanced head and neck cancers with Curcumin<br>Timepoint: Baseline, 1st, 2nd, 4th, 6th & 8th week of treatment. Subsequently Quality of life assessment every two months until six month of treatment<br><br>
- Secondary Outcome Measures
Name Time Method ilTimepoint: Nil