ABCSG C07/Exercise Details

Endurance training to reduce the relapse-rate after an adjuvant chemotherapy in patients with localised colorectal cancer

Start:
2010


Contact ABCSG-Trial office

E-mail: info@abcsg.at
Phone: +43 1 408 92 30
Fax: +43 1 409 09 90

Design

Abcsg-C07-Design
Click to enlarge

Primary objectives:

  • Feasibility of endurance exercise

Secondary objectives:

  • Increasing the efficiency
  • Quality of life (optional)

Inclusion criteria:

  • completely resected, histologically confirmed adenocarcinoma of the colon or rectum and status after (neo-)adjuvant therapy either in:
    • stage III or
    • stage II with risk factors (perforation, T4, G3 tumour, < 12 lymph nodes examined, vascular invasion, lymphangiosis)
  • patients, who have completed adjuvant chemotherapy 4-16 weeks prior to randomization
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Age ≥ 18 years
  • Adequate hematologic functions
  • Able to perform endurance exercise

Exclusion criteria:

  • Significant comorbid conditions precluding participation in a physical activity program
  • Reference to local recurrence, distant metastases
  • Reference of patients lack of cooperation
  • Past or current history of other malignant tumour diseases within in the last 5 years except basal cell carcinoma of the skin and/or in situ carcinoma of the cervix
  • Clinically significant cardiovascular disease:
    • unstable angina pectoris,
    • myocardial infarction < 6 month before randomization,
    • chronic heart failure NYHA II or higher,
    • serious arrhythmia,
    • syndromes of pre-excitement (eg Wolff-Parkinson-White-Syndrome),
    • high grade AV-Block,
    • permanent pacemaker stimulation,
    • uncontrolled hypertension (systolic blood pressure >150 mmHg),
    • aortic valve stenosis,
    • moderate or high-grade valve disease,
    • acute carditis (endo-, myo-, pericarditis),
    • acute aortic dissection,
    • acute pulmonary embolism,
    • acute phlebothrombosis of the lower extremity
  • current treatment with beta-blocker without opportunities to switch (beta-blocker changes the pulse rate and therefore the training plans)
  • left bundle branch block (pulse check by mean of pulse devise and LSB results in problems during the transfer)
  • current treatment with chemotherapy or radiotherapy
  • current pregnancy