Evaluation of Nano-curcumin Oral Formulation Efficacy as an Adjuvant Treatment in Metastatic Colorectal Patients

Backgrounds: Globally, colorectal cancer ranks as the second cause of mortality and the third most diagnosed cancer. Curcumin has been investigated as an adjunct therapy in various cancers, mostly in pre-clinical studies, particularly by acting as a chemo-sensitizer. Objectives: The present study aimed to evaluate the effectiveness of oral formulation of nano-curcumin as an adjuvant treatment in patients with metastatic colorectal cancer receiving the XELOX/FOLFOX±Bevacizumab regimen. Methods: In this study, 94 patients with metastatic colorectal cancer who completed the inclusion and exclusion criteria were randomized into the nano-curcumin and placebo groups. 40 mg nano-curcumin capsules were administered three times a day after each meal, beginning the first day to the end of the sixth cycle of chemotherapy. Carcinoembryonic antigen (CEA) level and radiological response based on Response Evaluation Criteria in Solid Tumors (RECIST version 1.1) were evaluated. The data were analyzed using SPSS version 13. Results: All baseline demographic, clinical, and laboratory variables were comparable between placebo and nano-curcumin groups. The administration of nano-curcumin showed no significant impact on carcinoembryonic antigen (CEA) levels. There was also no significant difference in both arms regarding RECIST criteria at the end of the 3rd and 6th cycle. Conclusion: Our findings suggest that nano-curcumin with the prescribed dose did not show considerable efficacy in the radiologic response of metastatic colorectal cancer based on RECIST criteria. The CEA serum level also did not change significantly in comparison with the placebo. Further research is needed to assess various nano-curcumin formulations, dosing, and timing for initiating curcumin for better judgment.