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

City of Hope

Status

Active, not recruiting

Conditions

Breast Cancer

Joint Pain

Treatments

Other: Nanoemulsion

Dietary Supplement: Curcumin

Other: Quality-of-Life Assessment

Behavioral: Questionnaire

Other: Placebo

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT03865992

UG1CA189823 (U.S. NIH Grant/Contract)

18432

NCI-2018-03787 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment

42 patients

Sex

Female

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

42 participants in 2 patient groups, including a placebo group

Arm I (nanoemulsion curcumin)

Experimental group

Description:

Patients receives nanoemulsion curcumin orally (PO) twice daily (BID) for up to 3 months in the absence of disease progression or unacceptable toxicity.

Treatment: