Evaluation of nano-curcumin oral formulation efficacy in prevention of chemotherapy-induced adverse reactions in metastatic colorectal cancer patients.

OBJECTIVE

The aim of the present study is to evaluate the effectiveness of oral formulation of nano-curcumin in prevention of some chemotherapy-induced adverse reactions.

MATERIALS AND

METHODS

In this study, 84 patients with metastatic colorectal cancer were randomly assigned into the nano-curcumin (40 mg capsule) or placebo groups, receiving treatments three times daily, beginning the first day to the end of the sixth cycle of chemotherapy. To investigate various adverse events, including hematologic adverse reactions, diarrhea, hand-foot syndrome (HFS) and neuropathy, the criteria of National Cancer Institute Common Terminology for Adverse Events (NCI-CTCAE) version 5 were implemented after the third and sixth course.

RESULTS

The CTCAE peripheral neuropathy score was significantly different between the two groups at the end of the 6th course (p=0.029) but not the third course (p=0.157). No significant response was observed for neutropenia, anemia, thrombocytopenia, HFS, or diarrhea at the end of both third (P=0.267, 0.258, 0.933, 0.377, and 0.811, respectively) and 6th courses (p=0.456, 0.645, 0.772, 0.34, and 0.114, respectively).

CONCLUSION

Nano-curcumin in dose of 40 mg thrice daily was not effective in prevention of neuropathy, HFS and hematologic adverse reactions induced by XELOX/FOLFOX-6 regimens. Further research with larger sample size on different nano-curcumin dosing schedules is suggested.