NCT04120298Active, not recruiting
Effects of Exercise in Patients With Metastatic Breast Cancer
Effects of Structured and Individualized Exercise in Patients With Metastatic Breast Cancer on Fatigue and Quality of Life
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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).
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 357 (actual)
- First submitted
- 12 Sept 2019
- Start date
- 8 Jan 2020
- Primary completion date
- 28 Feb 2023
- Lead sponsor
- UMC Utrecht
- Diseases
- Metastatic breast cancer
- NCT number
- NCT04120298
What you commit to
- Study type: Interventional
- Participants enrolled: 357
- From 8 Jan 2020 to the primary completion date, 28 Feb 2023
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Medical Center Utrecht Coordinator of this site? Confirm its status | Utrecht | Netherlands | Unknown status |
Related publications
This page is information, not medical advice. Discuss any trial with your doctor.