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Effects of Exercise in Patients With Metastatic Breast Cancer

NCT04120298 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 357

Last updated 2026-05-11

No results posted yet for this 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).

Conditions

Interventions

BEHAVIORAL

Supervised exercise

An individualised exercise programme supervised by a trained instructor

Sponsors & Collaborators

  • German Cancer Research Center

    collaborator OTHER

  • Australian Catholic University

    collaborator OTHER

  • Karolinska Institutet

    collaborator OTHER

  • The Netherlands Cancer Institute

    collaborator OTHER

  • Medical University of Gdansk

    collaborator OTHER

  • Fundación Onkologikoa Fundazioa

    collaborator UNKNOWN

  • Europa Donna

    collaborator UNKNOWN

  • German Sport University, Cologne

    collaborator OTHER

  • University Hospital Heidelberg

    collaborator OTHER

  • Nurogames GmbH, Cologne

    collaborator UNKNOWN

  • UMC Utrecht

    lead OTHER

Principal Investigators

  • Anne May, PhD · UMC Utrecht Julius Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-08
Primary Completion
2023-02-28
Completion
2027-07-01

Countries

  • Netherlands

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04120298 on ClinicalTrials.gov