IV Curcumin with Paclitaxel: RDBPCT in Women with Stage III or IV Breast Cancer
This was a phase II trial comparing IV curcumin with paclitaxel to IV placebo with paclitaxel in women (N=150) with locally advanced or metastatic breast cancer. While participants could have tumors with any receptor status, the majority (57%) had HR+/Her2(-) disease. Patients received IV therapy once weekly for 12 consecutive weeks as follows:
-Premedication with dexamethasone 8mg
-Active intervention (Curcumin 300mg with pharmaceutical grade emulsifier) or placebo (riboflavin 200mg) dissolved in 250mL NaCl
-Paclitaxel 80mg/m2 in 250mL NaCl
There were no complete responses in either group. However, there were significantly more partial responses in the curcumin group compared to placebo (51% vs 33%; p=0.0145). Three months after completion of treatment, ORR remained higher in the curcumin group (45% for patients who completed treatment with curcumin, versus 28% for those who received placebo; p=0.03), suggesting that efficacy may be maintained even after terminating treatment.
There were no significant differences in adverse events, with the exception of fatigue, which occurred more often in the placebo group (p=0.05). Allergic reactions did not differ between groups. There were no deaths during the trial.
Citation:
Saghatelyan et al. Efficacy and safety of curcumin in combination with paclitaxel in patients with advanced, metastatic breast cancer: A comparative, randomized, double-blind, placebo-controlled clinical trial. Phytomedicine. 2020 Apr 18;70:153218
Link:
https://www.sciencedirect.com/science/article/pii/S0944711320300507?via%3Dihub