A phase I study investigating the safety and pharmacokinetics of highly bioavailable curcumin (Theracurmin®) in cancer patients

Abstract

Repetitive systemic exposure to high concentrations of curcumin achieved by Theracurmin did not increase the incidence of adverse events in cancer patients receiving gemcitabine-based chemotherapy.

Colloidal Submicron-Particle Curcumin Exhibits High Absorption Efficiency—A Double-Blind, 3-Way Crossover Study—

“…Although the oral administration of 10 or 12 g of natural curcumin was safe in a previous clinical study (14), there is a possibility of unexpected side effects due to high plasma curcumin levels as a result of improvement of the absorption efficiency. Long-term administration of Theracurmin at a dose of 150 mg is safe and well-tolerated (24). Moreover, a 6-mo, ongoing clinical study using 180 mg of Theracurmin has so far indicated that Theracurmin at this dose is safe (Morimoto, unpublished data).…”

“…The total curcumin content in each preparation was considered to be approximately equal without breaking the capsules. Theracurmin was reported to be used at 100-400 mg in patients with cancer or healthy elderly volunteers for chronic treatment in clinical studies, indicating that at least 400 mg of Theracurmin was safe (24)(25)(26)(27). Moreover, more than 10 phase 2 clinical trials are now ongoing using 180 mg of Theracurmin, and no signifi cant adverse effect has been reported so far.…”

“…This is because there is a possibility of the degradation of curcumin itself and disintegration of its micelles due to instability caused by destroying preparations in an attempt to standardize the amount. The dosage of each curcumin preparation was determined based on recommended amounts for commercial use and clinical studies (17,21,(24)(25)(26)(27)(28)(29). The clinical benefi ts were obtained at these doses.…”

“…Nine subjects were enrolled in this study; the cohort included 5 males (56%), the cohort included 5 males and 4 females, with a mean age of 25 (24)(25)(26)(27)(28)(29)(30)(31)(32) Fig. 1.…”

Pharmacokinetic studies and anticancer activity of curcumin-loaded nanostructured lipid carriers

“…The most attractive and vital reason for the therapeutic use of curcumin is its superior safety profile. It has been demonstrated that curcumin has very low toxicity, even at very high doses (6). Nevertheless, native curcumin cannot reach the therapeutic target in a therapeutic concentration because of its low bioavailability.…”