Status:
ACTIVE_NOT_RECRUITING
Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease
Lead Sponsor:
City of Hope Medical Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Breast Cancer
Joint Pain
Eligibility:
FEMALE
Phase:
NA
Brief 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 ...
Detailed Description
PRIMARY OBJECTIVES: 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 post...
Eligibility Criteria
Inclusion
- 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")
Exclusion
- Prior malignancy =\< 5 years except adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, ductal carcinoma in situ of the breast or adequately treated stage I or II cancer from which the patient is currently in complete remission
- 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
Key Trial Info
Start Date :
March 4 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2026
Estimated Enrollment :
42 Patients enrolled
Trial Details
Trial ID
NCT03865992
Start Date
March 4 2019
End Date
September 8 2026
Last Update
November 7 2025
Active Locations (4)
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1
City of Hope Medical Center
Duarte, California, United States, 91010
2
City of Hope Rancho Cucamonga
Rancho Cucamonga, California, United States, 91730
3
City of Hope South Pasadena
South Pasadena, California, United States, 91030
4
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210