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Dietary Supplement
Curcumin for Joint Pain in Breast Cancer Survivors
N/A
Waitlist Available
Led By Lisa D Yee, MD
Research Sponsored by City of Hope Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Completion of definitive surgery with mastectomy or breast conserving therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 months
Awards & highlights
Study Summary
This trial will study how well curcumin works in reducing joint pain in breast cancer survivors with joint disease caused by treatment with aromatase inhibitors.
Who is the study for?
This trial is for postmenopausal breast cancer survivors with joint pain due to aromatase inhibitors. Participants must have had surgery for estrogen/progesterone-positive breast cancer and been on FDA-approved aromatase inhibitors for at least 90 days, planning to continue them. They should have a history of joint pain starting or worsening with the therapy.Check my eligibility
What is being tested?
The study tests if curcumin can reduce joint pain in these individuals compared to a placebo. Curcumin is derived from turmeric and may help arthritis-related discomfort. The trial includes taking curcumin or placebo, quality-of-life assessments, and questionnaires about the effect on joint pain.See study design
What are the potential side effects?
Potential side effects of curcumin may include digestive issues like upset stomach or nausea, allergic reactions for those sensitive to turmeric spices, and possibly interactions with certain medications that affect liver enzymes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been on an FDA-approved aromatase inhibitor for at least 90 days and plan to continue.
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I have completed surgery for breast cancer, either mastectomy or lumpectomy.
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I am postmenopausal or on treatment to suppress my ovaries for taking AIs.
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I have been diagnosed with early-stage breast cancer.
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I have had joint pain for 3 months or more, which started or got worse with AI therapy, and my worst pain score is 4 or higher.
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My breast cancer is positive for estrogen and/or progesterone receptors.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 3 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Brief Pain Inventory (BPI) pain score
Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy
Secondary outcome measures
Change in DASH score
Change in FACT-ES score
Incidence of adverse events
Other outcome measures
Adherence rates
Blood based biomarker analysis
Joint symptoms occurrence
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (nanoemulsion curcumin)Experimental Treatment4 Interventions
Patients receives nanoemulsion curcumin orally (PO) twice daily (BID) for up to 3 months in the absence of disease progression or unacceptable toxicity.
Group II: Arm II (placebo)Placebo Group1 Intervention
Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Curcumin
2017
Completed Phase 4
~1050
Questionnaire
2014
Completed Phase 2
~19970
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
570 Previous Clinical Trials
1,922,574 Total Patients Enrolled
42 Trials studying Breast Cancer
6,607 Patients Enrolled for Breast Cancer
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,321 Total Patients Enrolled
941 Trials studying Breast Cancer
1,543,924 Patients Enrolled for Breast Cancer
Lisa D Yee, MDPrincipal InvestigatorCity of Hope Medical Center
2 Previous Clinical Trials
105 Total Patients Enrolled
2 Trials studying Breast Cancer
105 Patients Enrolled for Breast Cancer
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