The purpose of this study is to assess whether a structured physical activity program (PA) during palliative chemotherapy improves progression-free survival (PFS) and/or patient-reported outcomes (ESAS-r) in patients with metastatic colorectal cancer.
While safety and feasibility as well as some improvements in fitness, fatigue and certain aspects of quality of life have been shown for physical activity in cancer patients during treatment, none of the pre-requisites above (i-iv) is fulfilled in the setting of patients with advanced colon cancer. However, evidence, primarily from the adjuvant setting, that physical activity impacts on treatment tolerability and tumor progression is a strong enough rationale to now embark on this prospective trial. By assessing in a large randomized controlled trial whether a 12-week structured physical activity program during chemotherapy in patients with newly diagnosed colorectal cancer undergoing standard first-line chemotherapy improves progression-free survival as compared to standard first-line chemotherapy alone, all pre-requisites for a practice-changing intervention are met. The physical exercise ACTIVE-program describes a 12-week exercise program consisting of a combination of a bi-weekly aerobic exercise (cycle ergometer) supervised by a physical therapist and a self-paced increase in physical activity during daily life using a pedometer with a daily step goal as a motivational tool. In addition to the supervised exercise program twice a week, patients of the intervention group are recommended to be physically active at home. All patients will undergo standard systemic therapy for metastatic colorectal cancer. Patients in the care-as-usual group are not actively encouraged to change their physical activity level e.g. to start a fitness program during chemotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Universitätsklinikum der PMU Salzburg
Salzburg, Austria
Progression-free survival (PFS)
Change between 2 tumor assessments
Time frame: every 8 or 9 weeks during one year
Change in Patient-reported symptoms as measured by ESAS-r
The ESAS-r is a summary score ranging from 0 to 100 with lower scores representing better quality of life of the patients.
Time frame: in at week 6, 12, 18, 24, 48
Overall survival
time from randomization to date of death. Patients without event at the time of analysis will be censored at the date they were last known to be alive.
Time frame: after progression (expected 1 year) lifelong follow-up
Best Objective Response
best tumor response achieved during first-line systemic therapy according to RECIST criteria. Only remission status achieved during first-line therapy will be considered.
Time frame: at week 8 or 9 during one year
Selected adverse events
assessed according to NCI CTCAE v4.0.
Time frame: day 1 of each cycle (every 8 or 9 weeks)
Chemotherapy-completion-rate
total dose in mg which was applied divided by the total dose in mg which was initially planned according to the planned chemotherapy scheme. Absolute doses of chemotherapy agents applied will be collected after each chemotherapy cycle. The total planned dose will be derived based on the planned chemotherapy scheme which is specified at baseline incorporating weight or body surface. The chemotherapy-completion-rate is defined as the number of dose modifications due to toxicity during the first 24 weeks after randomization per patient: after each 6 week-period (week 6, 12, 18, and 24) it is assessed whether there have been dose modifications (decrease/delay of systemic treatment i.e. chemo or biological) due to toxicity during the previous 6 weeks (y/n). The proportion of patients without any dose modification due to toxicity during the first 24 weeks will be calculated as well
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Klinikum Wels-Grieskirchen GmbH
Wels, Austria
Tumor Zentrum Aarau
Aarau, Switzerland
Kantonsspital Aarau
Aarau, Switzerland
Kantonsspital Baden
Baden, Switzerland
St. Claraspital
Basel, Switzerland
Clinical Cancer Research Center at University Hospital Basel
Basel, Switzerland
Istituto Oncologico della Svizzera Italiana IOSI
Bellinzona, Switzerland
Spitalzentrum Biel
Biel, Switzerland
Spitalzentrum Oberwallis
Brig, Switzerland
...and 14 more locations
Time frame: week 6, 12, 18, and 24
Initiation or increase of anti-hypertensive drugs
In the subgroup of patients who receive bevacizumab. The proportion of patients receiving new or increased doses of anti-hypertensive drugs will be calculated.
Time frame: day 1 of each cycle (every 8 or 9 weeks) for one year