An invivo study to evaluate the role of curcumin in oral pre-malignant lesions and gingivo-buccal cancers

INTERVENTION: Intervention1: Curcumin Capsule: 8 gms/day for 28 days Control Intervention1: Curcumin Lozenges: 400 mg/day for 28 days CONDITION: Pre‐malignant lesions (Head & neck cancers) PRIMARY OUTCOME: 1. To determine modulation of biologic endpoints (COX‐2, PGE‐2, Ki67, p53, bcl2 and antiphospho‐NFkB p65) in both premalignant lesions and invasive cancers; 2. To evaluate the pharmacokinetics and bioavailability of the topical (lozenge) and oral form of curcumin; 3. To evaluate the clinical response in these patients‐‐‐‐‐‐Timepoint: Baseline, Day 15 and Day 28 SECONDARY OUTCOME: Nil‐‐‐‐‐‐Timepoint: Nil INCLUSION CRITERIA: ? Age > 18 years ? Histologically confirmed resectable oral cavity cancer (T3, T4a) with a co‐existent premalignant condition i.e. leukoplakia or submucous fibrosis. ? Gives informed consent ? Previously untreated ? WHO performance status of < 1 ? Laboratory values (performed within 14 days prior to administration of Curcumin) ? WBC count > 3.0 x 109 /L ? Platelet count ≥ 150 x 109 /L ? Hemoglobin ≥ 10 gm/dl (100 gm/l) ? Serum creatinine less than 1.5 times the upper normal limit ? Total bilirubin less than 1.5 times the upper normal limit ? SGOT or SGPT ≤ 5.0 times upper limit of normal ? Negative Pregnancy test (female patients of childbearing potential only)