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

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.

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