Phase II/III Randomized Placebo Controlled Clinical Trial of Curcumin in Resectable Stage III and IV Squamous Head and Neck Cancers (Oral cancers)

Authors
Category Primary study
Registry of TrialsClinical Trials Registry - India
Year 2008
INTERVENTION: Intervention1: Curcumin Capsule: 3.6 gms/day for 6 months Control Intervention1: Placebo Capsule: 3.6 gms/day for 6 months CONDITION: Head & Neck Cancers PRIMARY OUTCOME: 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; ; ‐‐‐‐‐‐Timepoint: Baseline, 24 hrs, 7 days & 6 months for estimation of curcumin.; For rate of failure/recurrence: every 2 months for 6 months and thereafter every 2 months till recurrence or upto 2 years. SECONDARY OUTCOME: To evaluate curcumin induced modulation of biomarkers; ‐COX‐2/PGE2; ‐IL‐6; ‐‐‐‐‐‐Timepoint: Baseline, 24 hrs, 7 days & 6 months 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
Epistemonikos ID: fb472a89614615a72839ca2eb01fab3f0899f21e
First added on: Aug 21, 2024