NCT00702858已完成不适用
Pilot, Single Center Randomized Controlled, Double-Blind, Cross Over, Intent to Treat Trial of Blue Citrus to Placebo in Those Breast Cancer Patients Receiving Aromatase Inhibitor Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo
研究概览
简要总结
This purpose of this study is to determine if the herbal compound, Blue Citrus, decreases joint and bone pain associated with Aromotase Inhibitor therapy (AIT).
Another purpose of the study is to find out if Blue Citrus improves how you feel while taking AIT and if your quality of life improves.
详细描述
Post-menopausal women currently on AIT for breast cancer treatment who self-report musculoskeletal side effects related to AIT to their physicians.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Post Menopausal - evidenced by no menses for the past 6 months or FSH level >40
- •Patient complaints of musculoskeletal symptoms
- •Currently taking AIT for ER positive postmenopausal breast cancer
排除标准
- •Previously taken Blue Citrus
- •Presence of bone metastasis
- •Unable to complete VAS Pain Scale
- •Unable to comply/complete SF 12 Quality of Life survey
- •Plan to discontinue AIT in less then six months
- •Unable to complete ADL scale
- •Have diagnosis of fibromyalgia
- •Have diagnosis of rheumatoid arthritis
研究组 & 干预措施
1
Active Comparator
Blue Citrus either months 1-3 or 4-6
干预措施: Blue Citrus (Drug)
2
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Determine if Blue Citrus decreases musculoskeletal symptoms while on AIT as compared to Placebo
时间窗: 6 months
次要结局
- Determine if Blue Citrus use leads to reduction in use of other pain medications compared to placebo(6 months)
- Determine if Blue Citrus compared to placebo improves Quality of Life,improves the ability to perform Activities of Daily Living(6 months)
研究者
Nathalie Johnson
Principal Investigator
Legacy Health System
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