This phase I trial studies how well curcumin works in reducing joint pain in patients who are breast cancer survivors and have joint disease caused by treatment with aromatase inhibitors. Curcumin is an ingredient of turmeric, a plant in the ginger family, which is commonly used in curries and South Asian and Middle Eastern cooking, and may decrease joint pain in patients with arthritis from other conditions (such as osteoarthritis and rheumatoid arthritis).
Additional locations may be listed on ClinicalTrials.gov for NCT03865992.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVES:
I. To evaluate the feasibility of using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) scores to detect changes in aromatase inhibitor (AI)-induced symptoms and well-being in postmenopausal women with breast cancer at 3 months of nanoemulsion curcumin (NEC) versus (vs) placebo.
SECONDARY OBJECTIVES:
I. To evaluate Disabilities of the Shoulder, Arm, and Hand (DASH), Brief Pain Inventory, and Geriatric Assessment as secondary tools for monitoring AI-induced symptoms and well-being.
II. To evaluate the adherence to a regiment of NEC vs placebo by postmenopausal women experiencing joint arthropathy induced by aromatase inhibitor therapy.
III. To obtain preliminary data regarding function in women with AI induced arthropathy (IA) by monitoring grip strength at 0 and 3 months of NEC vs placebo.
IV. To conduct exploratory analyses of blood based biomarkers in postmenopausal women with AI-induced arthropathy taking NEC vs placebo.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive nanoemulsion curcumin orally (PO) twice daily (BID) for up to 3 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.
After completion of study, patients are followed up for 30 days.
Trial PhasePhase I
Trial Typesupportive care
Lead OrganizationCity of Hope Comprehensive Cancer Center
Principal InvestigatorLisa Diane Yee