Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease
NCT ID: NCT03865992
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
42 participants
INTERVENTIONAL
2019-03-04
2026-09-08
Brief Summary
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Detailed Description
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I. To evaluate the feasibility of using Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) scores to detect changes in AI-induced symptoms and well-being in postmenopausal women with breast cancer at 3 months of nanoemulsion curcumin (NEC) vs placebo
SECONDARY OBJECTIVES:
I. To evaluate Disabilities of the Arm, Shoulder and Hand (DASH), Brief Pain Inventory, and Geriatric Assessment as secondary tools for monitoring AI-induced symptoms and well-being II. To evaluate adherence to a regimen 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 versus 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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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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.
Curcumin
Given capsules for oral administration
Nanoemulsion
Given nanoemulsion curcumin PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire
Ancillary studies
Arm II (placebo)
Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.
Placebo
Given capsules for oral administration
Interventions
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Curcumin
Given capsules for oral administration
Placebo
Given capsules for oral administration
Nanoemulsion
Given nanoemulsion curcumin PO
Quality-of-Life Assessment
Ancillary studies
Questionnaire
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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")
Exclusion Criteria
* History of a bleeding tendency or current use of coumadin or other anticoagulants
* Current or previous history of anemia
* Current autoimmune, liver, hematopoietic, cardiac, or renal disease
* Current viral, bacterial, atypical or fungal infections of any organ system
* Concurrent use of immunosuppressant medications
* Concurrent use of medications known to inhibit or induce hepatic enzyme CYP 3A4 (e.g. ketoconazole, macrolide antibiotics, barbiturates)
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situation that would limit compliance with study requirements
* Bone fracture or surgery of the affected joints, within 180 days of study entry
* Medical therapy, alternative therapy, or physical therapy for joint pain/stiffness =\< 30 days of study entry
* Intra-articular steroids =\< 90 days of study entry or oral/intramuscular corticosteroids \< 30 days of entry
* Use of analgesics (e.g., opiates, tramadol with the exception of nonsteroidal anti-inflammatory drugs \[NSAIDs\] and acetaminophen) within 14 days prior to registration, or at any time during the 3-month study period
* Chronic use of any herbal or dietary supplement containing curcumin or curcuminoids =\< 3 months of study entry or any other supplements that might interact with NEC (e.g. St. John's Wort)
* Known sensitivity or allergy to turmeric spices or curry
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Lisa D Yee, MD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Medical Center
Duarte, California, United States
City of Hope Rancho Cucamonga
Rancho Cucamonga, California, United States
City of Hope South Pasadena
South Pasadena, California, United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States
Countries
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References
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Lustberg M, Fan-Havard P, Wong FL, Hill K, Phelps MA, Herrera KW, Tsai NC, Synold T, Feng Y, Kalu C, Sedrak MS, Yee LD. Randomized placebo-controlled, double-blind clinical trial of nanoemulsion curcumin in women with aromatase inhibitor-induced arthropathy: an Alliance/NCORP pilot trial. Breast Cancer Res Treat. 2024 May;205(1):61-73. doi: 10.1007/s10549-023-07223-4. Epub 2024 Jan 27.
Other Identifiers
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NCI-2018-03787
Identifier Type: REGISTRY
Identifier Source: secondary_id
18432
Identifier Type: OTHER
Identifier Source: secondary_id
18432
Identifier Type: -
Identifier Source: org_study_id