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Randomized Controlled Trial
. 2024 May;205(1):61-73.
doi: 10.1007/s10549-023-07223-4. Epub 2024 Jan 27.

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

Maryam Lustberg  1 , Patty Fan-Havard  2 , F Lennie Wong  3 , Kasey Hill  4 , Mitch A Phelps  4 , Kevin W Herrera  3 , Ni-Chun Tsai  3 , Timothy Synold  3 , Ye Feng  3 , Chidimma Kalu  3 , Mina S Sedrak  5 , Lisa D Yee  6   7
Affiliations
Randomized Controlled Trial

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

Maryam Lustberg et al. Breast Cancer Res Treat. 2024 May.

Abstract

Purpose: Aromatase inhibitor (AI) therapy reduces risk of recurrence and death for postmenopausal women with breast cancer (BC); however, AI-induced arthralgia (AIIA) can lead to discontinuation of treatment. Curcumin, a bioactive polyphenolic substance, may help ameliorate inflammation-related conditions including osteoarthritis and pain.

Methods: We conducted a multisite randomized placebo-controlled, double-blind pilot trial (Alliance A22_Pilot9) to evaluate the effects of nanoemulsion curcumin (NEC, 200 mg/day) in postmenopausal women experiencing AIIA for ≥ 3 months. The primary objective was to determine the feasibility of using Functional Assessment of Cancer Treatment-Endocrine Symptoms (FACT-ES) to detect changes from 0 (T0) to 3 months (T3) of NEC treatment in AI-induced symptoms and well-being; secondary objectives included evaluation of changes in Disabilities of the Shoulder, Arm, and Hand (DASH), Brief Pain Inventory-short form (BPI-SF), grip strength, and biomarkers at T0 and T3.

Results: Forty-two patients were randomized to NEC or placebo; 34 women completed the 3-month study. Patient-reported outcome measures (PROMs: FACT-ES, DASH, BPI-SF) and biospecimens were collected at T0-T3 in > 80% of participants. Adherence was ≥ 90% for both arms. PROMs and grip strength did not differ significantly by treatment arm. Plasma curcumin was detected only in NEC arm participants. Serum estradiol and estrone levels were below detection or low on study agent. Gastrointestinal adverse effects were commonly reported in both arms.

Conclusion: NEC versus placebo in a multisite randomized trial is feasible and well-tolerated. Additional studies with larger sample size are needed to further evaluate the efficacy and safety of NEC in treatment of AIIA.

Clinicaltrials: gov Identifier: NCT03865992, first posted March 7, 2019.

Keywords: Aromatase inhibitors-induced joint arthropathy; Nanoemulsion curcumin; Plasma curcumin levels; Plasma estrone and estradiol levels; Postmenopausal women.

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Conflict of interest statement

The authors have no relevant financial or non-financial interests to disclose.

Figures

Fig. 1
Fig. 1
CONSORT flow diagram
Fig. 2
Fig. 2
a–d Longitudinal analysis of FACT-ES, DASH, BPI severity, and BPI interference scores by GEE
Fig. 3
Fig. 3
≥ 2-point improvement in BPI severity by a total and b component scores
Fig. 4
Fig. 4
a Mean grip strength (kg) at T0 and T3 b Mean grip strength change T3–T0
Fig. 5
Fig. 5
Quantitative determination of plasma curcumin
See this image and copyright information in PMC

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