Content - SAKK 41/14

SAKK 41/14 ACTIVE-2 - Do colorectal cancer patients benefit from an exercise regimen?

Lack of movement can increase the risk of colorectal cancer. However, it is not known what effect physical activity has on patients with this condition. The SAKK 41/14 trial sets out to find if an exercise regimen can help alleviate the symptoms suffered by colorectal cancer patients and if movement possibly helps to improve the efficacy of treatment.

The trial is enrolling patients with advanced colorectal cancer for whom surgery is not an option. Participants will undertake a twelve-week exercise regimen that includes endurance training and keeping an exercise diary. They will also complete questionnaires on how they are feeling and take fitness tests at regular intervals.

 

Study Chair:

Prof. Dr. med. Viviane Hess, University Hospital Basel, +41 61 265 50 59

Further information

You will find further information on trial SAKK 41/14 at ClinicalTrials.gov.

Trial participation

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  • Contacts at the hospitals

  • Inclusion criteria

    • Written informed consent according to ICH/GCP regulations before randomization.
    • Patient with histologically or cytologically confirmed colorectal carcinoma (CRC) required to start palliative first-line systemic therapy for inoperable or metastatic disease.
    • Patients who were diagnosed with histologically or cytologically confirmed non-metastatic CRC earlier and now relapsed with metastatic disease are also eligible, if any prior neo-adjuvant or adjuvant chemotherapy has been completed more than 4 months before inclusion into this trial.
    • Patient has measurable disease on CT scan or MRI to be performed within 4 weeks before randomization (measurability criteria according to RECIST 1.1, non-nodal lesions ≥10 mm, lymph nodes ≥15mm) OR evaluable disease i.e. patient with non-measurable metastases but elevated serum tumor-marker (CEA at least >2xULN).
    • Command of written and spoken language allowing for informed consent and for filling in trial questionnaires.
    • Baseline patient-reported outcomes (PROs) have been completed.
    • WHO performance status 0-2.
    • Age 18-75 (80) years (if WHO is 0-1 upper age limit is 80 years).
  • Exclusion criteria

    • Any potential patient who meets any of the following criteria has to be excluded from entering the trial
    • Cycle ergometer stress test (completed within 28 days before trial start) shows significant signs of ischemic heart disease or high-grade arrhythmias, which preclude an exercise program.
    • Pre-existing severe medical conditions precluding participation in a physical activity program as determined by the local investigator. Such conditions include: chronic heart failure (greater than NYHA II), recent myocardial infarction (less than 3 months ago), unstable angina pectoris, clinically significant arrhythmias, uncontrolled hypertension with repeated systolic blood pressure above 160mmHg, and COPD (requiring oxygen supply or GOLD stadium greater than 2).
    • Inability to ride a cycle ergometer e.g. for musculoskeletal reasons.
    • Inability to perform 50 Watt on a cycle ergometer (during Cycle ergometer stress test), for any reason.
    • Patients who are a priori planned for curative surgery including metastasectomy. It is allowed to include patients for whom metastasectomy might be an option if chemotherapy induces a significant response.
    • Any serious underlying medical condition (at the judgment of the investigator) which could impair the ability of the patient to participate in the trial (e.g. active autoimmune disease, uncontrolled diabetes).
    • Concurrent treatment in a trial with experimental drugs or other anti-cancer therapy, which are hypothesized to alter tumor progression. Participation in an observational trial or a translational trial is allowed.
    • Previous malignancy within 5 years with the exception of adequately treated cervical carcinoma in situ, localized non-melanoma skin cancer, superficial bladder cancer (non-muscle invasive disease), localized prostate cancer (T1-3).
    • Psychiatric disorder precluding understanding of trial information, giving informed consent, filling out PRO forms, or interfering with compliance.
    • Any psychological, familial, sociological or geographical condition potentially hampering proper compliance with the trial protocol.

Locations for this trial:

Hirslanden Klinik Aarau
Schänisweg
0 5001 Aarau
Kantonsspital Aarau
Tellstrasse 25
0 5001 Aarau
Kantonsspital Baden
Im Ergel 1
4600 Baden
St. Claraspital AG
Kleinriehenstrasse 30
0 4058 Basel
Universitätsspital Basel
Petersgraben 4
0 4031 Basel
Istituto Oncologico della Svizzera Italiana IOSI
Via Ospedale
0 6500 Bellinzona
Spitalzentrum Biel
Vogelsang 84
0 2501 Biel
Spitalzentrum Oberwallis
Ueberlandstrasse 14
0 3902 Brig
Kantonsspital Graubünden
Loëstrasse 170
7000 Chur
Hôpital Fribourgeois HFR
Chemin des Pensionnats 2
1708 1708 Fribourg
Hôpitaux Universitaires de Genève HUG
Rue Gabrielle-Perret-Gentil 4
0 1205 Genève
Centre de Chimiothérapie Anti-Cancéreuse
-
0 1004 Lausanne
Kantonsspital Liestal
Rheinstrasse 26
0 4410 Liestal
Kantonsspital Luzern
Spitalstrasse
0 6000 Luzern
Kantonsspital Olten
Baslerstrasse 150
0 4600 Olten
Kantonsspital St. Gallen
Rorschacher Strasse 95
0 9007 St. Gallen
Spital STS AG Thun
Krankenhausstrasse 12
0 3600 Thun
Spital Thurgau, Kantonsspital Frauenfeld
Waldeggstrasse 8A
0 8501 Frauenfeld
Klinik Hirslanden Zürich
Witellikerstrasse 40
0 8032 Zürich
Klinik Hirslanden im Park
Seestrasse 259
0 8002 Zürich
Stadtspital Triemli
Birmensdorferstrasse 497
0 8063 Zürich
UniversitätsSpital Zürich
Rämistrasse 100
0 8091 Zürich
Landeskrankenhaus Salzburg - Universitätsklinikum
Müllner Hauptstraße 48
0 5020 Salzburg
Klinikum Wels-Grieskirchen
Grieskirchner Straße 42
0 4600 Wels