Improving Health of Women on Aromatase Inhibitors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Bone mineral density
研究概览
简要总结
This phase I/II trial studies how well dietary and exercise interventions work in reducing side effects in patients with stage I-IIIa breast cancer taking aromatase inhibitors. Anti-inflammatory Mediterranean dietary and bone strengthening exercise interventions may alleviate medication side effects such as joint and bone pain and protectively influence bone mineral density, improve heart functioning, and reduce risk of breast cancer recurrence in breast cancer patients taking aromatase inhibitors.
详细描述
PRIMARY OBJECTIVES:
I. To recruit an ethnically, racially and culturally diverse sample of postmenopausal women diagnosed with estrogen receptor positive breast cancer who are currently taking aromatase inhibitor (AI), establish eligibility, and randomly allocate 20 participants to a two-arm parallel intervention trial.
II. Conduct baseline measurements of: body composition and bone mineral density, reported muscle and joint pain; inflammatory, cardiovascular and bone health markers contained in blood serum; and, cardiovascular function.
III. Conduct a three month anti-inflammatory dietary intervention in one arm, and bone strengthening exercise intervention in the other study arm.
IV. At completion of these 3-month interventions, evaluate changes since baseline of body composition, bone density, reported muscle and joint pain, and inflammatory and cardiovascular measurements within each intervention arm, and preliminarily contrast changes between intervention 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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •At least 6 months since breast cancer diagnosis up to 2 years since diagnosis.
- •Diagnosed with localized breast cancer, up to stage IIIa.
- •Has been taking aromatase inhibitor (AIs) for at least six months.
- •Has been experiencing mild to moderate arthralgia (joint pain) for at least 2 months determined by the Brief Pain Inventory (BPI).
- •At least 6 months post chemotherapy or radiation treatment.
- •Subjects must be in good health as determined by medical history, physical examination, iDXA scan and clinical laboratory measurements.
- •Postmenopausal either natural or surgical or postmenopausal caused by ovarian suppression treatments administered to premenopausal women.
- •Currently taking aromatase inhibitor medication.
排除标准
- •Diagnosed with metastatic breast cancer.
- •Currently undergoing chemotherapy or radiation treatment.
- •Food allergies of any kind, or any medical condition requiring mandatory dietary restrictions.
- •A bone mineral density (BMD) T score less than -1, or fracture since taking AIs, or current use of glucocorticoids.
- •Taking bisphosphonates or any other medication for bone loss.
- •Significant cardiac, pulmonary, renal, liver or psychiatric disease.
- •Currently undergoing or engaging in a regular exercise program.
- •Muscular, orthopedic, or cardiovascular limitations that would prevent full participation in exercise.
- •Body mass index (BMI) greater than 40 kg/m^2.
结局指标
主要结局
Bone mineral density
时间窗: Baseline up to 1 week post intervention
Will be scanned by dual x-ray absorptiometry (iDXA).
Inflammatory markers
时间窗: Baseline up to 1 week post intervention
Fasting blood samples will be collected at baseline and end of intervention. Serum markers, IL-6, Il-8, TNF-?, MCP-1, hs-CRP, leptin, TGFbeta, IL-1beta, and CRP will be quantified.
Joint and muscle pain
时间窗: Baseline up to 1 week post intervention
Joint and muscle pain will be measured by the Brief Pain Inventory, a frequently administered assessment for studies of women on aromatase inhibitors (AIs). Participants will be asked about use of pain medication and supplements such as chondroitin and glucosamine. Subjects will also fill out standard visual analog scales to rate intensity of pain ranging from 1 to 10, as well as locate source of pain on standardized human figures available from International Society of Anesthetic Pharmacology. Additionally grip strength, a common marker of functional muscle and joint weakness, will be assessed using a dynamometer.
次要结局
未报告次要终点