ACTRN12611000019909已完成2 期
Phase II randomised, placebo-controlled study to evaluate the efficacy of topical pure emu oil for arthralgic pain related to aromatase inhibitor use in postmenopausal women with early breast cancer: JUST joints under pain
Breast Cancer Research Centre of Western Australia0 个研究点目标入组 75 人开始时间: 2011年1月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- o limit 至 o limit（—）
- 性别
- Female
入选标准
- •1. ECOG 0-1
- •2. Post menopausal early breast cancer patients with endocrine- responsive disease who are recommended for an aromatase inhibitor and have received an aromatase inhibitor for a minimum of 3 months and is planned to continue on the same aromatase inhibitor for at least a further 6 months
- •3. Prior adjuvant chemotherapy (including trastuzumab and bevacizumab) are permitted
- •4. Joint pain +/- stiffness in one or more joints which has subjectively worsened whilst on an aromatase inhibitor
- •5. Able to complete a joint pain severity and stiffness assessment using a 5-point visual analogue score and ability to complete the BPI assessment tool
- •6. Patients consent to not commencing any other, topical or non-steroidal strategy aimed specifically at alleviating arthralgia during study period. However, oral analgesics are permitted.
排除标准
- •1. Hypersensitivity to oleic acid or linolenic acid
- •2. Rheumatoid arthritis or any arthritic disease (with exclusion of osteoarthritis)
- •3. Patients who have received immunosuppressant medication or corticosteroids within the preceding 3 months (inhaled corticosteroids are permitted eg inhalers for asthma)
- •4. Patients who are receiving any topical medicine for joint stiffness or pain
- •5. Any other clinical condition that contradicts the use of the investigational agent (eg. Hypersensitivity or allergy to any ingredients of either oil) or that may affect patients compliance with study routines or place the patient at high risk from treatment complications
研究者
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