EUCTR2016-002435-15-ES进行中(未招募)1 期
Pilot study to assess physical exercise intervention in neoadjuvant treatment with nab-paclitaxel in patients with triple negative breast cancer - OncoExer
Fundación de Investigación HM Hospitales0 个研究点开始时间: 2017年6月9日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1.- Women with TNBC stages II and III (A, B).
- •2.- Women = 18 years old.
- •3.- Patients with a tumor size = 2 cm, N0, N1-2.
- •4.- Patients able to start a physical exercise program (if randomized to that arm) in the same week that starting neoadjuvant chemotherapy.
- •5.- Patientes that dedicate < 60 minutes of physical activity per week.
- •6.- Patients that declare to be not smokers/drinker at the time of diagnosis.
- •7.- Patients with Cholesterol value <200 at the time of diagnosis.
- •8.- Patients No diagnosed with hyperthyroidism or hypothyroidism.
- •9.- No diagnosed with diabetes.
- •10.- Patients with an echocardiogram > 50%.
- •11.- Bone mass index between 18,5 and 25.
- •12.- No additional treatments that might interfere with the current protocol.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.- Patients with a history of chronic disease (Diabetes, not controlled high blood pressure, thyroid disease).
- •2.- Patients with a weight loss >10% in the past 6 months.
- •3.- Patients with metastatic disease.
- •4.- Patients with cardiovascular, pulmonary or biomotor problems that might contraindicate physical exercise.
- •5.- Patients that declare to be smokers/drinker at the time of diagnosis.
- •6.- Patients with Cholesterol value >200 at the time of diagnosis.
- •7.- Patients diagnosed with hyperthyroidism or hypothyroidism.
- •8.- Patients diagnosed with diabetes.
- •9.- Patients with an echocardiogram < 50%.
- •10.- Patientes with additional treatments that might interfere with the current protocol.
研究者
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