Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study

Who is this study for? Patients who are breast cancer survivors and have joint disease caused by treatment with aromatase inhibitors
What treatments are being studied? Curcumin+Nanoemulsion
Status: Active_not_recruiting
Location: See all (4) locations...
Intervention Type: Other, Dietary supplement, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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).

Eligibility
Participation Requirements
Sex: Female
Healthy Volunteers: f
View:

• Women with histologically confirmed primary invasive adenocarcinoma of the breast, stages I-IIIA

• Estrogen-receptor positive (ER+) and/or progesterone-receptor positive (PR+) breast cancer

• Completion of definitive surgery with mastectomy or breast conserving therapy

• Postmenopausal (no menses \>= 12 months) or on ovarian suppression in order to take AIs

• Currently taking an Food and Drug Administration (FDA) approved third-generation aromatase inhibitor (e.g., anastrozole \[Arimidex\], letrozole \[Femara\], or exemestane \[Aromasin\]) for \>= 90 days prior to registration with plans to continue for \>= 90 days after registration

• Clinical symptoms of joint pain for at least 3 months prior to study entry that started or increased with AI therapy with Brief Pain Inventory (BPI) Worst Pain score \>= 4 (verbal response to BPI question 3 regarding the worst pain in the past 24 hours as 0 no pain to 10 pain as bad as you can imagine)

Locations
United States
California
City of Hope Medical Center
Duarte
City of Hope Rancho Cucamonga
Rancho Cucamonga
City of Hope South Pasadena
South Pasadena
Ohio
Ohio State University Comprehensive Cancer Center
Columbus
Time Frame
Start Date: 2019-03-04
Completion Date: 2025-10-17
Participants
Target number of participants: 42
Treatments
Experimental: Arm I (nanoemulsion curcumin)
Patients receives nanoemulsion curcumin orally (PO) twice daily (BID) for up to 3 months in the absence of disease progression or unacceptable toxicity.
Placebo_comparator: Arm II (placebo)
Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.
Related Therapeutic Areas
Sponsors
Leads: City of Hope Medical Center
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov