Effects of Exercise in Patients With Metastatic Breast Cancer

  • STATUS
    Recruiting
  • End date
    Jul 1, 2027
  • participants needed
    350
  • sponsor
    UMC Utrecht
Updated on 1 December 2021

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).

Description

The EFFECT study is a multicentre, randomised controlled trial. The intervention group will participate in a 9-month exercise intervention. The exercise program will start with a 6-month period, where patients participate in a supervised multimodal exercise program twice a week supplemented with unsupervised exercises. The multimodal exercise program comprises aerobic-, resistance- and balance components. After completing the initial six-month period, one supervised session will be replaced by one unsupervised session until month nine.

Unsupervised exercises will be supported by an activity tracker (FitBit) and an exercise App specifically designed for the EFFECT trial. Patients randomized to the control group will also receive an activity tracker (like the intervention group). The investigators will advice control patients to avoid inactivity and be as physically active as current abilities and conditions allow, with the aim to progress towards being physically active for 150min/week in line with the current exercise guidelines.

Details
Condition Stage IV Breast Cancer, Metastatic Breast Cancer
Treatment Supervised exercise
Clinical Study IdentifierNCT04120298
SponsorUMC Utrecht
Last Modified on1 December 2021

Eligibility

Yes No Not Sure

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
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