Curcumin for Breast Cancer Survivors With Aromatase Inhibitor-Induced Joint Arthropathy - A Randomized, Double-Blinded, Controlled Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 42
- 试验地点
- 4
- 主要终点
- Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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")
排除标准
- •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
研究组 & 干预措施
Arm II (placebo)
Patients receive placebo PO BID for up to 3 months in the absence of disease progression or unacceptable toxicity.
干预措施: Placebo (Other)
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.
干预措施: Nanoemulsion (Other)
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.
干预措施: Quality-of-Life Assessment (Other)
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.
干预措施: Questionnaire (Behavioral)
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.
干预措施: Curcumin (Dietary Supplement)
结局指标
主要结局
Changes in aromatase inhibitor-induced symptoms and overall wellbeing in postmenopausal women on aromatase inhibitor therapy
时间窗: 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.
Change in Brief Pain Inventory (BPI) pain score
时间窗: 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.
次要结局
- Incidence of adverse events(Up to 30 days post study-drug assessment)
- Change in FACT-ES score(Baseline up to 3 months)
- Change in DASH score(Baseline up to 3 months)