The study protocol, Combining curcumin (C3-complex, Sabinsa) with standard care FOLFOXchemotherapy 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.