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Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease

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ClinicalTrials.gov Identifier: NCT03865992
Recruitment Status : Recruiting
First Posted : March 7, 2019
Last Update Posted : September 2, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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 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).

Condition or disease Intervention/treatment Phase
Breast Cancer Joint Pain Dietary Supplement: Curcumin Other: Placebo Other: Nanoemulsion Other: Quality-of-Life Assessment Behavioral: Questionnaire Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study
Actual Study Start Date : March 4, 2019
Estimated Primary Completion Date : July 31, 2020
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Curcumin

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.
Dietary Supplement: Curcumin
Given capsules for oral administration
Other Names:
  • C.I. 75300
  • C.I. Natural Yellow 3
  • Diferuloylmethane
  • Turmeric Yellow
  • (E,E)-1,7-Bis(4-hydroxy-3-methoxyphenyl)-1,6-heptadiene-3,5-dione, 32982, 458-37-7

Other: Nanoemulsion
Given nanoemulsion curcumin PO

Other: Quality-of-Life Assessment
Ancillary studies
Other Name: Quality of Life Assessment,

Behavioral: Questionnaire
Ancillary studies
Other Name: Questionnaires

Placebo Comparator: Arm II (placebo)
Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.
Other: Placebo
Given capsules for oral administration
Other Names:
  • placebo therapy
  • PLCB
  • sham therapy




Primary Outcome Measures :
  1. 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.

  2. Change in Brief Pain Inventory (BPI) pain score [ Time Frame: Baseline up to 3 months ]
    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.


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: Up to 30 days post study-drug assessment ]
    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.

  2. 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

  3. 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.


Other Outcome Measures:
  1. Joint symptoms occurrence [ Time Frame: Up to 3 months ]
    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.

  2. Blood based biomarker analysis [ Time Frame: Up to 3 months ]
    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.

  3. Adherence rates [ Time Frame: Up to 3 months ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03865992


Locations
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United States, California
City of Hope Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Lisa D. Yee, MD    626-218-7461    lyee@coh.org   
Principal Investigator: Lisa D. Yee, MD         
City of Hope Rancho Cucamonga Not yet recruiting
Rancho Cucamonga, California, United States, 91730
Contact: Valerie Estalla    626-256-4673 ext 81699    vestalla@coh.org   
City of Hope South Pasadena Not yet recruiting
South Pasadena, California, United States, 91030
Contact: Odessa Rodriguez    626-256-4673    orodriguez@coh.org   
United States, Ohio
Ohio State University Comprehensive Cancer Center Not yet recruiting
Columbus, Ohio, United States, 43210
Contact: Maryam B. Lustberg    614-293-0066    Maryam.Lustberg@osumc.edu   
Principal Investigator: Maryam B. Lustberg         
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Lisa D Yee, MD City of Hope Medical Center

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Responsible Party: City of Hope Medical Center
ClinicalTrials.gov Identifier: NCT03865992     History of Changes
Other Study ID Numbers: 18432
NCI-2018-03787 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
18432 ( Other Identifier: City of Hope Medical Center )
UG1CA189823 ( U.S. NIH Grant/Contract )
First Posted: March 7, 2019    Key Record Dates
Last Update Posted: September 2, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by City of Hope Medical Center:
Breast cancer
curcumin
aromatase inhibitor
joint pain
arthropathy
Additional relevant MeSH terms:
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Enzyme Inhibitors
Breast Neoplasms
Arthralgia
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Curcumin
Aromatase Inhibitors
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists