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临床试验/NCT03956641
NCT03956641Unknown不适用

Evolution of the Physical Condition in Treated Cancer Patients

Centre Paul Strauss2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年9月17日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
300
试验地点
2
主要终点
evolution of exercise tolerance

研究概览

简要总结

Adaptated Physical Activity (APA) during treatment of cancer is one of the actual global health recommendation because of the benefits observed in several parameters evaluated in many clinical studies. A best knowledge of the physical and medical characteristics of patients, including type of cancer and type of treatment, is primordial to optimize the patient care and the effectiveness of APA programs.

Descriptive, explorative and prospective study of 3 different populations:

One population with locally advanced or metastatic non-small cell lung cancer treated with multiple therapeutic lines. Two different populations of early cancer patients and treated with a platinum-based regimen for colon cancer and a taxane-based chemotherapy for breast cancer.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Woman with breast cancer treated with adjuvant chemotherapy (taxane) or patient with colon cancer treated with adjuvant regimen (FOLFOX) or patient with locally advanced or metastatic lung cancer
  • Patient without contraindication to the study-specific assessments
  • Eastern Cooperative Oncology Group ≤ 2
  • Age ≥ 18 years old
  • Life expectancy > 6 months
  • Able to speak, read and understand French
  • Written informed consent obtained from the patient
  • Registration in a national health care system

排除标准

  • Patient with psychiatric, neurologic or musculoskeletal disorders
  • Pregnant or breastfeeding women
  • Minor or protected adult

结局指标

主要结局

evolution of exercise tolerance

时间窗: change from baseline exercise tolerance at 12 weeks after the end of the treatment

To describe exercise tolerance, by a six-minute walk test, in patients treated for a cancer (of lung, breast or colon) after 8 weeks of treatment.

次要结局

  • measurement of the lean body mass condition(change from baseline physical condition at 12 weeks after the end of the treatment)
  • measurement of the pulmonary function(change from baseline physical condition at 12 weeks after the end of the treatment)
  • measurement of parameters reflecting the physical condition(change from baseline physical condition at 12 weeks after the end of the treatment)

研究者

发起方
Centre Paul Strauss
申办方类型
Other
责任方
Sponsor

研究点 (2)

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