Status:
ACTIVE_NOT_RECRUITING
Effects of Exercise in Patients With Metastatic Breast Cancer
Lead Sponsor:
UMC Utrecht
Collaborating Sponsors:
German Cancer Research Center
Australian Catholic University
Conditions:
Metastatic Breast Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 stud...
Detailed 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2027
Estimated Enrollment :
357 Patients enrolled
Trial Details
Trial ID
NCT04120298
Start Date
January 8 2020
End Date
July 1 2027
Last Update
December 6 2023
Active Locations (1)
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1
University Medical Center Utrecht
Utrecht, Netherlands