Curcumin Chemoprevention Trial
Oral leukoplakia is a potentially malignant lesion of the oral cavity, for which no effective treatment is available. We investigated the effectiveness of curcumin, a potent inhibitor of NF-B/COX-2, molecules perturbed in oral carcinogenesis, to treat leukoplakia. Subjects with oral leukoplakia (n = 223) were randomized (1:1 ratio) to receive orally, either 3.6 g/day of curcumin (n = 111) or placebo (n = 112), for 6 months. The primary endpoint was clinical response obtained by bi-dimensional measurement of leukoplakia size at recruitment and 6 months. Histologic response, combined clinical and histologic response, durability and effect of long-term therapy for an additional six months in partial responders, safety and compliance were the secondary endpoints. Clinical response was observed in 75 (67.5%) subjects [95% confidence interval (CI), 58.4–75.6] in the curcumin and 62 (55.3%; 95% CI, 46.1–64.2) in placebo arm (P = 0.03). This response was durable, with 16 of the 18 (88.9%; 95% CI, 67.2–96.9) subjects with complete response in curcumin and 7 of 8 subjects (87.5%) in placebo arm, demonstrating no relapse after 6 months follow-up. Difference in histologic response between curcumin and placebo was not significant (HR, 0.88, 95% CI, 0.45–1.71; P = 0.71). Combined clinical and histologic response assessment indicated a significantly better response with curcumin (HR, 0.50; 95% CI, 0.27–0.92; P = 0.02). Continued therapy, in subjects with partia...
Source: Cancer Prevention Research - Category: Cancer & Oncology Authors: Kuriakose, M. A., Ramdas, K., Dey, B., Iyer, S., Rajan, G., Elango, K. K., Suresh, A., Ravindran, D., Kumar, R. R., R, P., Ramachandran, S., Kumar, N. A., Thomas, G., Somanathan, T., Ravindran, H. K., Ranganathan, K., Katakam, S. B., Parashuram, S., Jayap Tags: Research Articles Source Type: research