Feasibility study of combined aerobic exercise and strength training during neoadjuvant chemotherapy for resectable adenocarcinoma of the stomach or gastroesophageal junction.
- Conditions
- locally advanced adenocarcinoma of the stomach or gastroesophageal junction (AEG I-III)C16Malignant neoplasm of stomach
- Registration Number
- DRKS00005607
- Lead Sponsor
- Klinikum rechts der Isar der TU München
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 20
1.) Histologically verified, resectable Adenocarcinoma of the stomach or the esophageal-gastric-junction (AEG I-III), stage uT2 - uT4 without distant metastases.
2.) age = 18 years
3.) 3.) ECOG Status 0-2
4.) negative pregnancy test for women of childbearing-potential
5.) Sufficient bone-marrow, hepatic and renal function by assessment of the treating oncologist
1.) non-resectable primary tumour by assessment of the treating surgeon.
2.) Participation in an interventional trial with interefering primary endpoint.
3.) pregnancy or breat-feeding
4.) severe cardiac comorbidities (instable angina pectoris, congestive heat failure NYHA IV, malignent arteriell Hypertension).
5.) severe pulmonary comorbidities (COPD GOLD IV)
6.) Muscoloskeletall comorbidities (e.g. coxarthritis, Gonarthritis) that significantly limit mobility
7.) lack of compliance
8.) other reasons that impede physical exercise training
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Postoperative Morbidity and Mortality according to Dindo-Clavien Grade II-IV
- Secondary Outcome Measures
Name Time Method 1.) number of patients enrolled within the recruiting period<br>2.) number of screened patients<br>3.) Number of patients that finish the exercise training (compliance)<br>4.) drop-out rate