In continuation of two earlier related studies, researchers at the University of Leicester in the U.K. 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 toward 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. Results were published in the Journal of Nutrition.
 
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 concluded 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, PhD, 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.
 
A previous research article on a two-part study, Curcumin  inhibits  cancer  stem  cell  phenotypes in ex vivo models of colorectal liver metastases, and is clinically safe and tolerable in combination with FOLFOX chemotherapy, was published in Cancer Letters in  2015 (doi: 10.1016/j.canlet.2015.05.005). The first part of the study included an ex vivo model to test the efficacy of the curcumin and FOLFOX therapy on cancer liver metastases. The second part included a phase I dose escalation study, which evaluated the safety and tolerability of curcumin during FOLFOX chemotherapy. Overall, the study results indicated that the combination of curcumin and 5-FU/oxaliplatin reduced the number of spheroids and downregulated cancer stem cells markers such as CD44, CD166, and ALDH activity. In the phase I dose escalation study, curcumin was found to be safe and tolerable up to a dose of 2 g in the colorectal cancer with liver metastases subjects.