- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03865992
Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease
Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study
Study Overview
Status
Conditions
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 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Duarte, California, United States, 91010
- City of Hope Medical Center
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Rancho Cucamonga, California, United States, 91730
- City of Hope Rancho Cucamonga
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South Pasadena, California, United States, 91030
- City of Hope South Pasadena
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Ohio
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Columbus, Ohio, United States, 43210
- Ohio State University Comprehensive Cancer Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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 Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Ancillary studies
Other Names:
Given capsules for oral administration
Other Names:
Given nanoemulsion curcumin PO
Ancillary studies
Other Names:
|
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.
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Given capsules for oral administration
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy
Time Frame: Up to 3 months
|
The study will assess the feasibility of using the Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES) to detect changes in aromatase inhibitor (AI)-induced symptoms and well-being in postmenopausal women with breast cancer randomized to 3 months of nanoemulsion curcumin (NEC) versus (vs) placebo capsules.
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Up to 3 months
|
Change in Brief Pain Inventory (BPI) pain score
Time Frame: Baseline up to 3 months
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The scores obtained from the Disabilities of the Arm, Shoulder and Hand (DASH) and BPI, and FACT-ES assessments will be plotted over time for each arm.
The agreement between these instruments will be evaluated using Altman and Bland plot after proper data transformation.
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Baseline up to 3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of adverse events
Time Frame: Up to 30 days post study-drug assessment
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Adverse events will be characterized using the descriptions and grading scales found in the most recent version of the Common Terminology Criteria for Adverse Events version 5.0.
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Up to 30 days post study-drug assessment
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Change in FACT-ES score
Time Frame: Baseline up to 3 months
|
The scores obtained from the BPI, DASH, and FACT-ES assessments will be plotted over time for each arm.
The agreement between these instruments will be evaluated using Altman and Bland plot after proper data transformation
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Baseline up to 3 months
|
Change in DASH score
Time Frame: Baseline up to 3 months
|
The scores obtained from the BPI, DASH, and FACT-ES assessments will be plotted over time for each arm.
The agreement between these instruments will be evaluated using Altman and Bland plot after proper data transformation.
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Baseline up to 3 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Joint symptoms occurrence
Time Frame: Up to 3 months
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The study will use logistic regression models to compare the occurrence of moderate to severe joint symptoms during the 3 month period between the two study groups, with potential covariates including geriatric assessment (GA), age, body mass index, baseline pain scores (0 month), prior chemotherapy e.g.
taxanes, time to menopause/ovarian suppression.
Summary statistics will be generated using the data obtained from the T0 and T3 study visits where grip strength dynamometry completed.
Temporal as well as other relevant correlations between the data and the validated assessment scores will be determined.
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Up to 3 months
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Blood based biomarker analysis
Time Frame: Up to 3 months
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The study will explore the relationship between specific inflammatory blood markers, grip strength, and the joint symptoms evaluated by the patient reported outcome measures.
The relationship between plasma curcumin and these measures will also be evaluated.
Scatter plots and correlation coefficients (either Pearson or Spearman) will be used to summarize their pair wise relation.
The differences between the treatment and placebo in terms of these measures will also be reported using numerical summaries and graphic plots.
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Up to 3 months
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Adherence rates
Time Frame: Up to 3 months
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Adherence rates will be examined using pill counts each month and patient recorded daily logs.
Plasma curcumin will be compared to daily logs and pill count data as another potential measure of adherence.
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Up to 3 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Lisa D Yee, MD, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms
- Neoplasms by Site
- Pain
- Neurologic Manifestations
- Breast Diseases
- Joint Diseases
- Musculoskeletal Diseases
- Breast Neoplasms
- Arthralgia
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Antineoplastic Agents
- Curcumin
Other Study ID Numbers
- 18432 (Other Identifier: City of Hope Medical Center)
- UG1CA189823 (U.S. NIH Grant/Contract)
- NCI-2018-03787 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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