Clinical trial · Interventional
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
NCT04120298CI-TRIAL-00111086EFFECTactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Supervised exercise | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Supervised exercise group
- description
- 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
- interventionNames
- Behavioral: Supervised exercise
- type
- NO_INTERVENTION
- label
- Control group
- description
- 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.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (6)
- DERIVEDZopf EM, Joernaker G, Clauss D, Trevaskis M, Hiensch AE, Schmidt ME, Monninkhof EM, Zimmer P, Belloso J, Heyrman E, Fernandez Gonzalo R, Wiskemann J, Muller J, Bolam KA, Gorecki M, Altena R, Muttiah C, van der Wall E, Aaronson NK, Senkus E, Urruticoechea A, Stuiver MM, Steindorf K, Bloch W, Wengstrom Y, May AM, Rundqvist H. Exercise effects on lean body mass, muscle strength and functional performance in patients with metastatic breast cancer: the randomized controlled PREFERABLE-EFFECT study. Breast Cancer Res. 2026 Apr 13;28(1):98. doi: 10.1186/s13058-026-02235-6. PMID 41975453
- DERIVEDKias 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. PMID 40714912
- DERIVEDSchouten 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. PMID 39805062
- DERIVEDHiensch 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.