NCT02597075

Physical Activity in Patients With Metastatic Colorectal Cancer Who Receive Palliative First-line Chemotherapy

Physical Activity in Patients With Metastatic Colorectal Cancer Who Receive Palliative First-line Chemotherapy. A Multicenter Open Label Randomized Controlled Trial

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Swiss Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Metastatic Colorectal Cancer

Interventions

Type	Name	Description
OTHER	standard therapy + physical activity program
OTHER	standard therapy

Timeline

• Start date: 2016-03-17
• Primary completion: 2021-09-21
• Completion: 2021-11-30
• First posted: 2015-11-04
• Last updated: 2022-11-07

Locations

24 sites across 2 countries: Austria, Switzerland