In continuation of two earlier related studies, researchers at the University of Leicester in the UK published the results of a phase IIa, open-labeled trial in which 27 subjects with metastatic colorectal cancer were randomized to take FOLFOX or FOLFOX + Curcumin C3 Complex (CUFOX). The study was directed towards the evaluation of safety, and efficacy of treatment via progression-free survival and overall survival. In general, CUFOX was well tolerated by all the subjects. Where causality was reported as possibly or probably related to curcumin were primarily gastrointestinal in nature, with the most common being diarrhea. In the per-protocol group median progression-free survival was 171 days for FOLFOX and 320 days for CUFOX. Median overall survival was 200 days for FOLFOX and 596 days for CUFOX. This is the first randomized controlled trial of CUFOX in metastatic colorectal subjects which has shown the safety and tolerability of CUFOX in subjects.
The authors conclude that “…combination of curcumin with FOLFOX chemotherapy represents a safe and tolerable treatment with potential to provide patient benefit.” and that a phase III trial is warranted.
“Research examining the use of drugs and nutraceuticals together is an exciting new direction to investigate,” said N. Kalyanam, Ph.D., Sabinsa’s President of R&D. “Sabinsa continues to build on science and contribute to the extensive knowledge base of curcumin for better health for all.”
The study, Curcumin Combined with FOLFOX Chemotherapy Is Safe and Tolerable in Patients with Metastatic Colorectal Cancer in a Randomized Phase IIa Trial, was published in the Journal of Nutrition: doi/10.1093/jn/nxz029/5499032.
The study protocol, Combining curcumin (C3-complex, Sabinsa) with standard care FOLFOX chemotherapy in patients with inoperable colorectal cancer (CUFOX): study protocol for a randomized control trial, was previously published in Trials 2015 and can be accessed here: doi.org/10.1186/s13063-015-0641-1.