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

Mahdi Jannati  Yazdan Abad; Abolghasem  Allahyari; Mostafa  Kamandi; Omid  Arasteh; Mehdi  Varmaghani; Hedyieh  Karbasforooshan; Mahmoud Reza  Jaafari; Sepideh  Elyasi

doi:10.18502/jpc.v13i1.18401

Mahdi Jannati Yazdan Abad Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
Abolghasem Allahyari Department of Hematology-Oncology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Mostafa Kamandi Department of Hematology-Oncology, Faculty of Medicine, Mashhad University of Medical Sciences, Mashhad, Iran.
Omid Arasteh Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
Mehdi Varmaghani Social Determinants of Health Research Center, Mashhad University of Medical Sciences, Mashhad, Iran.
Hedyieh Karbasforooshan Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.
Mahmoud Reza Jaafari Nanotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran.
Sepideh Elyasi Department of Clinical Pharmacy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran.

DOI: https://doi.org/10.18502/jpc.v13i1.18401

Keywords: Metastatic Colorectal Cancer; Nano-curcumin; Chemotherapy Toxicity; Cancer Progression; FOLFOX/ XELOX ± Bevacizumab

Abstract

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.