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Clinical Trials in the Netherlands / NCT04120298
Active, not recruiting Not applicable

Effects of Exercise in Patients With Metastatic Breast Cancer

NCT04120298 · tracked via the Priya Life Science Netherlands tracker
Phase
Not applicable
Started
2020-01-08
Last updated
2026-05-11

Condition(s) studied

Metastatic Breast Cancer

Investigational drug(s) / intervention(s)

Supervised exercise

Supervised exercise: An individualised exercise programme supervised by a trained instructor

Study summary

Currently, the effect of exercise on metastatic breast cancer has not been extensively studied, even though the benefits are evident in the curative setting. The investigators designed the EFFECT study to assess the effects of a 9-month structured and individualised exercise intervention in 350 patients with metastatic breast cancer (stage IV) on cancer-related physical fatigue, Health-Related Quality of Life (HRQoL), and other disease and treatment-related side effects at six months (primary endpoint).

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of breast cancer stage IV * ECOG (Eastern Cooperative Oncology Group scale) performance status ≤ 2 * Able and willing to perform the exercise program and wear the activity tracker Exclusion Criteria: * A potential subject who meets any of the following criteria is not eligible for enrolment into this study: * Unstable bone metastases inducing skeletal fragility as determined by the treating clinician * Untreated symptomatic known brain metastasis * Estimated life expectancy \< 6 months as determined by the treating clinician * Serious active infection * Too physically active (i.e. \>210 minutes/week of moderate-to-vigorous intentional exercise * Severe neurologic or cardiac impairment according ACSM criteria * Uncontrolled severe respiratory insufficiency as determined by the treating clinician or if the patient is dependent on oxygen suppletion in rest or during exercise * Uncontrolled severe pain * Any other contraindications for exercise as determined by the treating physician * Any circumstances that would impede adherence to study requirements or ability to give informed consent, as determined by the treating clinician * Pregnancy

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
University Medical Center Utrecht Utrecht Netherlands

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04120298 on ClinicalTrials.gov ↗ ← All trials in the Netherlands