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

NCT ID: NCT02597075

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-17
• Study Completion Date: 2021-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Arm A: with ST + PA

Standard therapy + structured Physical activity and pedometer

Group Type: ACTIVE_COMPARATOR

standard therapy + physical activity program

Intervention Type: OTHER

Arm B:

Standard therapy

Group Type: ACTIVE_COMPARATOR

standard therapy

Intervention Type: OTHER

Interventions

standard therapy + physical activity program

Intervention Type: OTHER

standard therapy

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Written informed consent according to ICH/GCP regulations before randomization.
• Patient with histologically or cytologically confirmed colorectal carcinoma (CRC) who start palliative first-line systemic therapy for inoperable or metastatic disease.

Note: Patients can be included before the start or within the first three weeks of first-line systemic treatment.

• Patients with histologically or cytologically confirmed colorectal carcinoma (CRC), who start first-line "conversion"-therapy for borderline resectable metastatic disease and will be reassessed for metastasectomy after 3-4 months of systemic treatment.

Note: Patients can be included before the start or within the first three weeks of first-line systemic treatment.

Patients who are diagnosed with metastatic disease and were initially treated with surgery and/or radiochemotherapy to the primary tumor are eligible (except if all disease sites/metastases have been removed) Patients who have been curatively treated with histologically or cytologically confirmed nonmetastatic CRC previously and now relapse with metastatic disease are also eligible, irrespective of previous radiochemotherapy and/or adjuvant chemotherapy

• Patients must have measurable disease on CT scan or MRI to be performed within 6 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 nonmeasurable 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 years

Exclusion Criteria

• 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.
• Patients in whom all CRC metastases have been removed surgically. 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. Palliative radiotherapy is allowed.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Viviane Hess, Prof Dr med

Role: STUDY_CHAIR

University Hospital, Basel, Switzerland

Locations

Universitätsklinikum der PMU Salzburg

Salzburg, , Austria

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

Kantonsspital Graubünden

Chur, , Switzerland

Hôpital Fribourgeois HFR

Fribourg, , Switzerland

Hôpitaux Universitaires de Genève

Geneva, , Switzerland

Centre de Chimiothérapie Anti-Cancéreuse

Lausanne, , Switzerland

Kantonsspital Baselland

Liestal, , Switzerland

Kantonsspital Luzern

Lucerne, , Switzerland

Spital Thurgau

Münsterlingen, , Switzerland

Kantonsspital Olten

Olten, , Switzerland

Kantonsspital - St. Gallen

Sankt Gallen, , Switzerland

SpitalSTS AG Simmental-Thun-Saanenland

Thun, , Switzerland

Onkozentrum - Klinik im Park

Zurich, , Switzerland

Onkozentrum Hirslanden Zürich

Zurich, , Switzerland

Stadtspital Triemli

Zurich, , Switzerland

UniversitätsSpital Zurich

Zurich, , Switzerland

Countries

Austria; Switzerland

Other Identifiers

2015-003733-10

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2015-003733-10

Identifier Type: OTHER

Identifier Source: secondary_id

SAKK 41/14 - ACTIVE-2

Identifier Type: -

Identifier Source: org_study_id