跳至主要内容
临床试验/EUCTR2016-002435-15-ES
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

发起方
Fundación de Investigación HM Hospitales

相似试验