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临床试验/NCT04894149
NCT04894149Unknown不适用

Prehabilitation and Rehabilitation for Patients With Oesophageal Cancer

Gabriella Alexandersson von Döbeln1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2021年4月22日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
25
试验地点
1
主要终点
Adherence to exercise sessions.

研究概览

简要总结

Patients with oesophageal cancer selected for oncological and surgical treatment with curative intent are offered supervised physiotherapy and home-based training before and after surgery.

详细描述

Patients with loco-regional oesophageal cancer who will receive neoadjuvant chemotherapy or chemoradiotherapy followed by surgery and sometimes adjuvant chemotherapy are eligible to be enrolled in the trial. Study treatment is supervised group training twice weekly and home-based training three times weekly during neoadjuvant treatment and after surgery.

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

  • Histopathologically confirmed squamous cell carcinoma, adenocarcinoma or adenosquamous carcinoma in the oesophagus or cardia (Siewert I or II), cT1 N+ or cT2-4a any N, M0, according to the 8th version of the AJCC TNM classification.
  • Assessed at a multidisciplinary conference to be suitable for curatively intended oncological and surgical treatment.
  • Age > 18 years.
  • Performance status ECOG 0-
  • Patient has provided written informed consent.

排除标准

  • Previous radiotherapy in the thorax (except for tangential field radiotherapy for breast cancer).
  • Inability to understand written and spoken instructions and to comply with protocol requirements.

结局指标

主要结局

Adherence to exercise sessions.

时间窗: Up to 40 weeks

Percentage of sessions completed out of number of sessions planned

Un-planned interruptions in the prehabilitation/rehabilitation programme

时间窗: Up to 40 weeks

Percentage of patients having an unplanned interruption of ten days or more of the supervised prehabilitation/rehabilitation programme

次要结局

未报告次要终点

研究者

发起方
Gabriella Alexandersson von Döbeln
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Gabriella Alexandersson von Döbeln

Principal Investigator

Karolinska University Hospital

研究点 (1)

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