Trial document




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  DRKS00005607

Trial Description

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Title

Feasibility study of combined aerobic exercise and strength training during neoadjuvant chemotherapy for resectable adenocarcinoma of the stomach or gastroesophageal junction.

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Trial Acronym

SPIN-Pilot

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URL of the Trial

[---]*

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Brief Summary in Lay Language

In the proposed study we investigate whether a combined aerobic exercise and strength training under chemotherapy before operation for stomach cancer is feasible. The control group receives neoadjuvant treatment without training according to current guidelines.

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Brief Summary in Scientific Language

In the proposed randomised-controlled pilot study we investigate the feasibility of a combined aerobic exercise and strength training under neoadjuvant chemotherapy in patients with resectable adenocarcinoma of the stomach or the gastroesophageal junction (AEG I-III). According to current German S3- guidelines neoadjuvant chemotherapy is indicated in adenocarcinomas of the stomach or the gastroesophageal junction (AEG I-III) in UICC stage Ib-IIC (without distant metastases). Surgical resection following neoadjuvant chemotherapy is associated with a high postoperative complication rate of up to 40%. Pulmonary and cardiac complications contribute substantially to this complication rate. We hypothesize that aerobic exercise and strength training during the neoadjuvant phase can improve cardiac and pulmonary functioning and would result in a reduction of postoperative morbidity and mortality. Patients in the control group will receive standard neoadjuvant chemotherapy without sport intervention. To increase compliance and reduce the Hawthorne effect, patients in the control group will receive a postoperative sport exercise training after discharge from the hospital.

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Organizational Data

  •   DRKS00005607
  •   2014/04/10
  •   [---]*
  •   yes
  •   Approved
  •   95/14, Ethik-Kommission der Fakultät für Medizin der Technischen Universität München
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C16 -  Malignant neoplasm of stomach
  •   locally advanced adenocarcinoma of the stomach or gastroesophageal junction (AEG I-III)
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Interventions/Observational Groups

  •   Preoperative combined aerobic exercise and strength training during neoadjuvant Chemotherapy for 10-12 weeks. Training occurs in 2 phases:
    - supervised exrcise training: twice weekly under supervision for 60min each.
    - hometraining: once a week
    each session last 60min.
  •   neoadjuvant chemotherapy.
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Characteristics

  •   Interventional
  •   [---]*
  •   Randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   No treatment
  •   Prevention
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Postoperative Morbidity and Mortality according to Dindo-Clavien Grade II-IV

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Secondary Outcome

1.) number of patients enrolled within the recruiting period
2.) number of screened patients
3.) Number of patients that finish the exercise training (compliance)
4.) drop-out rate

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Planned
  •   2014/06/01
  •   20
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

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

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Exclusion Criteria

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

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Addresses

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    • Klinikum rechts der Isar der TU München
    • Ismaninger Str. 22
    • 81675  München
    • Germany
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    • Klinikum rechts der Isar,Technische Universität München
    • Mr.  Dr.med. M.Sc.  Andre L.  Mihaljevic 
    • Ismaningerstr. 22
    • 81675  München
    • Germany
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    • Klinikum rechts der Isar,Technische Universität München
    • Mr.  Dr.med. M.Sc.  Andre L.  Mihaljevic 
    • Ismaningerstr. 22
    • 81675  München
    • Germany
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Sources of Monetary or Material Support

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    • Chirurgische Klinik und Poliklinik,Klinikum rechts der Isar,Technische Universität München
    • Mr.  Dr.med. M.Sc.  Andre  Mihaljevic 
    • Ismaningerstr. 22
    • 81675  München
    • Germany
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Status

  •   Recruiting planned
  •   [---]*
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.