Randomized placebo-controlled, double-blind clinical trial of nanoemulsion curcumin in women with aromatase inhibitor-induced arthropathy: an Alliance/NCORP pilot trial

This was a multisite randomized, placebo-controlled, double-blind pilot trial. Postmenopausal women with ER- and/or PR-positive breast cancer receiving aromatase inhibitor therapy and having at least 3 months of AI-related arthralgia were enrolled; the NEC arm included 19 participants and the placebo arm included 15 participants.

Nanoemulsion curcumin (NEC) was given orally as capsules at a total dose of 200 mg/day of curcumin, dosed as 1 capsule twice daily for 3 months. The active capsules contained approximately 100 mg curcuminoids each and were compared with placebo in a double-blind trial.

NEC was feasible and well tolerated, but it did not show clear efficacy for aromatase inhibitor-induced arthropathy in this small pilot study. FACT-ES change at 3 months favored NEC (+7.1, SD 15.6) over placebo (-7.4, SD 15.0), with between-arm p=0.039, but other patient-reported outcomes and grip strength did not show significant between-arm differences. Within-arm FACT-ES changes were not significant (NEC p=0.08; placebo p=0.14), and grip strength results were mixed (right hand p=0.44, left hand p=0.07; combined increase >2 kg in 7 NEC readings vs 4 placebo readings, p=0.05). Plasma curcumin was detectable in NEC-treated participants with available 3-month samples (n=14), supporting exposure. Larger trials are needed because this pilot was not powered for efficacy and the significant finding was not adjusted for multiple comparisons.

Small sample size and pilot design limit inference, and the study was not powered to assess efficacy. The 3-month duration was short, multiple outcome testing was not adjusted, and several outcomes showed no significant between-arm differences. Some subgroup/assay data were incomplete, which further limits interpretation.