A Randomized Double-Blind Placebo-Controlled Phase IIB Trial of Curcumin in Oral Leukoplakia

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-κB/COX-2, molecules perturbed in oral carcinogenesis, to treat leukoplakia. Subjects with oral leukoplakia (n...

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Published in:Cancer prevention research (Philadelphia, Pa.) Vol. 9; no. 8; pp. 683 - 691
Main Authors: Kuriakose, Moni Abraham, Ramdas, Kunnambath, Dey, Bindu, Iyer, Subramanya, Rajan, Gunaseelan, Elango, Kalavathy K, Suresh, Amritha, Ravindran, Divya, Kumar, Rajneesh R, R, Prathiba, Ramachandran, Surya, Kumar, Nisha Asok, Thomas, Gigi, Somanathan, Thara, Ravindran, Hiran K, Ranganathan, Kannan, Katakam, Sudhakar Babu, Parashuram, Shivashankar, Jayaprakash, Vijayvel, Pillai, M Radhakrishna
Format: Journal Article
Language:English
Published: United States 01.08.2016
Subjects:
Administration, Oral
Adult
Aged
Antineoplastic Agents - administration & dosage
Antineoplastic Agents - adverse effects
Antineoplastic Agents - therapeutic use
Biopsy
Blood Cell Count
Curcumin - administration & dosage
Curcumin - adverse effects
Curcumin - therapeutic use
Cyclooxygenase 2 - metabolism
Double-Blind Method
Female
Humans
Leukoplakia, Oral - drug therapy
Leukoplakia, Oral - pathology
Male
Middle Aged
NF-kappa B - antagonists & inhibitors
Placebos
Time Factors
Treatment Outcome
ISSN:1940-6215
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Summary: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-κB/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 partial response at 6 months, did not yield additional benefit. The treatment did not raise any safety concerns. Treatment of oral leukoplakia with curcumin (3.6 g for six months), thus was well tolerated and demonstrated significant and durable clinical response for 6 months. Cancer Prev Res; 9(8); 683-91. ©2016 AACR.
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ISSN:1940-6215
DOI:10.1158/1940-6207.CAPR-15-0390