A recent clinical trial published in The Journal of Nutrition adds to the existing body of evidence that curcumin can be used safely as an adjuvant therapy with cancer drugs. In the current phase IIa, open-label trial, 27 subjects with metastatic colorectal cancer were randomized to receive folinic acid/5-fluorouracil/oxaliplatin chemotherapy (FOLFOX) or FOLFOX with Curcumin C3 Complex, from Sabinsa Corp. (East Windsor, NJ). The primary outcome of the study was to evaluate safety and tolerability of this combination of curcumin and FOLFOX, and then the secondary outcome was determining any clinical benefit.
Results showed that the combination of FOLFOX and curcumin was safe and well tolerated. While there were more adverse events reported in the group taking the combination, this group also had a higher median number of chemotherapy cycles, 12 cycles compared to three cycles in the FOLFOX group. When researchers expressed the adverse events as “per cycle” events, they found no statistically significant differences between the groups in adverse event reports. Adverse events that could be associated with the consumption of curcumin were gastrointestinal in nature, with one participant ceasing the consumption of curcumin to end their nausea.
Researchers also observed statistical differences between the two groups in overall survival of participants. For the group taking FOLFOX alone, the median overall survival was 200 days, compared to 596 days for the group taking both curcumin and FOLFOX, with a six-month overall survival of 55.6% and 93.3%, respectively. However, the researchers do concede that despite these significant differences, there were factors that may have contributed to survival bias in the small cohort, such as differences in tumor staging and the number of metastatic sites. Additionally, median overall survival rates in the combination group were in line with expectations of standard FOLFOX treatment, and the FOLFOX group had poorer overall survival than was expected.
Taking all these results into consideration, having established the safety and tolerability of combining curcumin with FOLFOX, further study is now warranted to assess the use of curcumin as an adjuvant therapy in a phase III trial.
1. Howells LM et al. “Curcumin combined with FOLFOX chemotherapy is safe and tolerable in patients with metastatic colorectal cancer in a randomized phase IIa trial.” The Journal of Nutrition, Published online ahead of print on May 27, 2019