Phase II/III Randomized Placebo Controlled Clinical Trial of Curcumin in Resectable Stage III and IV Squamous Head and Neck Cancers (Oral cancers)
Phase 2
Completed
- Registration Number
- CTRI/2008/091/000195
- Lead Sponsor
- DBT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 160
Inclusion Criteria
1. Histologically confirmed squamous cancers of oral cavity
2. Stage III-IV (resectable lesions)
3. Karnofsky?s scale > 60%
4. Patients selected to undergo curative treatment (otherwise generally fit patients)
5. Patient has signed and dated the Informed Consent Document
6. Patient is willing and able to fully participate for the duration of the study
Exclusion Criteria
1. All patients with unresectable lesions
2. Poor Karnofsky?s scale
3. Patients with non-squamous cancers.
4. Patients who does not comply with assigned
complete treatment protocol.
5. Patients with potential behavior and cognitive
impairment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the efficacy of curcumin in subjects with histologically proven resectable stage III and IV squamous cancers of the head and neck (to monitor the rate of failure / recurrences) following standard treatment<br><br>Timepoint: Baseline, 24 hrs, 7 days & 6 months for estimation of curcumin.<br>For rate of failure/recurrence: every 2 months for 6 months and thereafter every 2 months till recurrence or upto 2 years.
- Secondary Outcome Measures
Name Time Method To evaluate curcumin induced modulation of biomarkers<br>-COX-2/PGE2<br>-IL-6<br>Timepoint: Baseline, 24 hrs, 7 days & 6 months