Clinical trial NCT03865992: Curcumin in Reducing Joint Pain in Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Disease
Official title: Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Joint Pain
Keywords: Breast cancer
curcumin
aromatase inhibitor
joint pain
arthropathy
Lead sponsor: City of Hope Medical Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-03-07
Enrollment: 42
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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.

Eligibility 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

Primary outcomes:
measure: Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy
timeFrame: Up to 3 months
measure: Change in Brief Pain Inventory (BPI) pain score
timeFrame: Baseline up to 3 months
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: Up to 30 days post study-drug assessment
measure: Change in FACT-ES score
timeFrame: Baseline up to 3 months
measure: Change in DASH score
timeFrame: Baseline up to 3 months
Other outcomes:
measure: Joint symptoms occurrence
timeFrame: Up to 3 months
measure: Blood based biomarker analysis
timeFrame: Up to 3 months
measure: Adherence rates
timeFrame: Up to 3 months
Locations:
city: Duarte
country: United States
facility: City of Hope Medical Center
state: California
city: Rancho Cucamonga
country: United States
facility: City of Hope Rancho Cucamonga
state: California
city: South Pasadena
country: United States
facility: City of Hope South Pasadena
state: California
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: City of Hope Medical Center
name: Lisa D Yee, MD
role: PRINCIPAL_INVESTIGATOR
References: