Clinical Trials

Combination treatment with curcumin and quercetin of adenomas in familial adenomatous polyposis

Cruz-Correa M, Shoskes DA, Sanchez P, Zhao R, Hylind LM, Wexner SD, Giardiello FM. Clinical Gastroenterology Hepatology. 2006, 4(8):1035-8.

Five FAP patients with prior colectomy (4 with retained rectum and 1 with an ileal anal pouch) received curcumin 480 mg and quercetin 20 mg orally 3 times a day. The number and size of polyps were assessed at baseline and after therapy. The Wilcoxon signed-rank test was used to determine differences in the number and size of polyps. Treatment side effects and medication compliance also were evaluated. All 5 patients had a decreased polyp number and size from baseline after a mean of 6 months of treatment with curcumin and quercetin. The mean percent decrease in the number and size of polyps from baseline was 60.4% (P < .05) and 50.9% (P < .05), respectively. Minimal adverse side effects and no laboratory abnormalities were noted.

CONCLUSIONS: The combination of curcumin and quercetin appears to reduce the number and size of ileal and rectal adenomas in patients with FAP without appreciable toxicity. Randomized controlled trials are needed to validate these findings.

Effect of turmeric on urinary mutagens in smokers

Polasa K, Raghuram TC, Krishna TP, Krishnaswamy K. Mutagenesis, 1992;7:107-9.

In the present study, anti-mutagenic effects of turmeric were assessed in 16 chronic smokers.

It was observed that turmeric, given in doses of 1.5 g/day for 30 days, significantly reduced the urinary excretion of mutagens in smokers.

In contrast, in six non-smokers, who served as control, there was no change in the urinary excretion of mutagens after 30 days.

Turmeric had no significant effect on serum aspartate aminotransferase and alanine aminotransferase, blood glucose, creatinine and lipid profile.

These results indicate that dietary turmeric is an effective anti-mutagen and it may be useful in chemoprevention.

Phase II trial of curcumin in patients with advanced pancreatic cancer

N. Dhillon, B. B. Aggarwal, R. A. Wolff, J. L. Abbruzzese, D. S. Hong, L. H. Camacho, L. Li, F. S.Braiteh, R. Kurzrock

• The only FDA-approved therapies- gemcitabine and erlotinib- produce objective responses in less than 10% of patients.
• The objectives of this trial were to evaluate the toxicity and activity of curcumin, as well as its impact on survival and biologic correlates.
• Patients were treated with 8 grams of curcumin (Sabinsa Corp.) daily by mouth for two months and evaluated radiographically using the RECIST criteria.
• Maintenance therapy was continued at the same dose and schedule until disease progression.
• RESULTS: Seventeen patients were enrolled as of the date of analysis.
• Six were inevaluable: noncompliance (n=1), never dosed (n= 1), noted to have gastric obstruction after one dose (n=1), and too early (n=3).
• Eleven patients were evaluable for response and 15 were evaluable for toxicity.
• To date, four patients have stable disease (2+, 2+, 3+ and 7 months) and one patient had a brief partial remission (73% reduction in tumor size by RECIST) that lasted one month.
• No toxicity was observed. Serum was available for evaluation of pre-and post-dose cytokine levels in thirteen patients. Interestingly, the patient with the partial remission had marked increases in (4-35 fold) in serum IL-1 receptor antagonist, IL-6, IL-10 and IL-8 levels. One to three other patients also had post-treatment increases one or more of the above cytokines, albeit to a lesser extent (2-6 folds).

CONCLUSIONS: We conclude that curcumin is well tolerated and our preliminary results suggest biologic activity in pancreatic cancer.