Effects of Exercise in Patients With Metastatic Breast Cancer
NCT ID: NCT04120298
Last Updated: 2023-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
357 participants
INTERVENTIONAL
2020-01-08
2027-07-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Supervised exercise group
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
Supervised exercise
An individualised exercise programme supervised by a trained instructor
Control group
Patients randomized to the control group will also receive an activity tracker (like the intervention group). We 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.
No interventions assigned to this group
Interventions
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Supervised exercise
An individualised exercise programme supervised by a trained instructor
Eligibility Criteria
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Inclusion Criteria
* ECOG (Eastern Cooperative Oncology Group scale) performance status ≤ 2
* Able and willing to perform the exercise program and wear the activity tracker
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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German Cancer Research Center
OTHER
Australian Catholic University
OTHER
Karolinska Institutet
OTHER
The Netherlands Cancer Institute
OTHER
Medical University of Gdansk
OTHER
Fundación Onkologikoa Fundazioa
UNKNOWN
Europa Donna
UNKNOWN
German Sport University, Cologne
OTHER
University Hospital Heidelberg
OTHER
Nurogames GmbH, Cologne
UNKNOWN
UMC Utrecht
OTHER
Responsible Party
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Dr. Anne May
Cancer Epidemiologist
Principal Investigators
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Anne May, PhD
Role: PRINCIPAL_INVESTIGATOR
UMC Utrecht Julius Center
Locations
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University Medical Center Utrecht
Utrecht, , Netherlands
Countries
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References
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Kias A, Schmidt ME, Hiensch AE, Clauss D, Monninkhof EM, Pelaez M, Belloso J, Gunasekara N, Sweegers MG, Trevaskis M, Rundqvist H, Muller J, Wiskemann J, van der Wall E, Aaronson NK, Lachowicz M, Urruticoechea A, Zopf EM, Bloch W, Stuiver MM, Wengstrom Y, May AM, Steindorf K. Factors Associated With Employment and Quality of Working Life in Patients With Metastatic Breast Cancer. Cancer Med. 2025 Aug;14(15):e71074. doi: 10.1002/cam4.71074.
Schouten AEM, Hiensch AE, Frederix GWJ, Monninkhof EM, Schmidt ME, Clauss D, Gunasekara N, Belloso J, Trevaskis M, Rundqvist H, Wiskemann J, Muller J, Sweegers MG, Fremd C, Altena R, Bijlsma RM, Sonke G, Lahuerta A, Mann GB, Francis PA, Richardson G, Malter W, Kufel-Grabowska J, van der Wall E, Aaronson NK, Senkus E, Urruticoechea A, Zopf EM, Bloch W, Stuiver MM, Wengstrom Y, Steindorf K, van der Meulen MP, May AM. Supervised Exercise for Patients With Metastatic Breast Cancer: A Cost-Utility Analysis Alongside the PREFERABLE-EFFECT Randomized Controlled Trial. J Clin Oncol. 2025 Apr 10;43(11):1325-1336. doi: 10.1200/JCO-24-01441. Epub 2025 Jan 13.
Hiensch AE, Depenbusch J, Schmidt ME, Monninkhof EM, Pelaez M, Clauss D, Gunasekara N, Zimmer P, Belloso J, Trevaskis M, Rundqvist H, Wiskemann J, Muller J, Sweegers MG, Fremd C, Altena R, Gorecki M, Bijlsma R, van Leeuwen-Snoeks L, Ten Bokkel Huinink D, Sonke G, Lahuerta A, Mann GB, Francis PA, Richardson G, Malter W, van der Wall E, Aaronson NK, Senkus E, Urruticoechea A, Zopf EM, Bloch W, Stuiver MM, Wengstrom Y, Steindorf K, May AM. Supervised, structured and individualized exercise in metastatic breast cancer: a randomized controlled trial. Nat Med. 2024 Oct;30(10):2957-2966. doi: 10.1038/s41591-024-03143-y. Epub 2024 Jul 25.
Pelaez M, Stuiver MM, Broekman M, Schmitz KH, Zopf EM, Clauss D, Wengstrom Y, Rosenberger F, Steindorf K, Urruticoechea A, May AM. Early Detection of Brain Metastases in a Supervised Exercise Program for Patients with Advanced Breast Cancer: A Case Report. Med Sci Sports Exerc. 2023 Oct 1;55(10):1745-1749. doi: 10.1249/MSS.0000000000003213. Epub 2023 May 12.
Hiensch AE, Monninkhof EM, Schmidt ME, Zopf EM, Bolam KA, Aaronson NK, Belloso J, Bloch W, Clauss D, Depenbusch J, Lachowicz M, Pelaez M, Rundqvist H, Senkus E, Stuiver MM, Trevaskis M, Urruticoechea A, Rosenberger F, van der Wall E, de Wit GA, Zimmer P, Wengstrom Y, Steindorf K, May AM. Design of a multinational randomized controlled trial to assess the effects of structured and individualized exercise in patients with metastatic breast cancer on fatigue and quality of life: the EFFECT study. Trials. 2022 Jul 29;23(1):610. doi: 10.1186/s13063-022-06556-7.
Related Links
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Website of the EFFECT study within the PREFERABLE project
Twitter account PREFERABLE project
Other Identifiers
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NL69600.041.19
Identifier Type: OTHER
Identifier Source: secondary_id
19-524
Identifier Type: -
Identifier Source: org_study_id