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Metastatic Breast CancerEFFECTNCT04120298

Effects of Exercise in Patients With Metastatic Breast Cancer

A study testing Supervised exercise in people with Metastatic Breast Cancer, run by UMC Utrecht at 1 site in Netherlands.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Metastatic Breast Cancer
What is being tested?
Supervised exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
357 participants
Where
1 siteNetherlands
Study dates
8 Jan 2020to 1 Jul 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • University Medical Center Utrecht

    Utrecht

Other trials in Netherlands

About this study

Official title: Effects of Structured and Individualized Exercise in Patients With Metastatic Breast Cancer on Fatigue and Quality of Life

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).

Read the 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 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.

Being tested
Supervised exercise
Keywords
exercise, cancer-related fatigue, quality of life
Medical subject headings
Breast Neoplasms, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Supervised exerciseBehavioural

    An individualised exercise programme supervised by a trained instructor

Study groups in NCT04120298
Study groupRoleWhat they receive
Supervised exercise groupExperimentalThe 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
Receives: Behavioral: Supervised exercise
Control groupNo interventionPatients 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cancer-related physical fatigue

    Physical fatigue measured with the EORTC QLQ-FA12

    Measured: 0- 6 months (measured at baseline, 3 and 6 months)

  2. Health-related Quality of Life

    Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score

    Measured: 0- 6 months (measured at baseline, 3 and 6 months)

Secondary outcomes (27)

  1. Separate HRQoL domains and Summary Score

    EORTC QLQ-C30 function and symptom scores scores

    Measured: 0-9 months

  2. Cancer-related fatigue

    EORTC QLQ-FA12 scores

    Measured: 0-9 months

  3. Breast cancer specific symptoms

    EORTC QLQ-BR45

    Measured: 0-9 months

  4. Anxiety, depression

    PHQ-4

    Measured: 0-9 months

  5. Sleep

    PSQI

    Measured: 0-9 months

  6. Pain: severity and its impact on functioning.

    BPI

    Measured: 0-9 months

  7. Neuropathic pain

    painDETECT

    Measured: 0-9 months

  8. Pain Catastrophizing

    PCS

    Measured: 0-9 months

  9. Treatment-related toxicities grade≥3

    Common Toxicity Criteria for adverse events (CTCAE)

    Measured: 0-9 months

  10. Weight

    weight measured in KG

    Measured: 0-6 months

  11. Height

    Height measured in meters

    Measured: 0-6 months

  12. Waist circumference

    waist circumference measured in cm

    Measured: 0-6 months

  13. Body composition (fat free mass and fat mass)

    Bioelectrical impedance analysis (BIA), add-on in some centers (not obligatory): DEXA

    Measured: 0-6 months

  14. Physical activity (subjective)

    Questionnaire

    Measured: 0-6-9 months

  15. Physical activity (objective)

    activity tracker

    Measured: 0-6-9 months

  16. Resting heart rate

    Resting heart rate

    Measured: 0-6 months

  17. Blood pressure

    Blood pressure (diastolic and systolic) measured at rest

    Measured: 0-6 months

  18. Physical performance

    Short Physical Performance Battery, handgrip- and leg strength test

    Measured: 0-6 months

  19. Physical fitness

    Steep ramp test and endurance cycle test, add-on (not obligatory): CPET

    Measured: 0-6 months

  20. Work status/ healthcare resources consumption

    iPCQ/iMCQ

    Measured: 0-9 months

  21. Intervention costs

    Cost analyses

    Measured: 0-9 months

  22. Health status

    EQ-5D-5L

    Measured: 0-9 months

  23. Satisfaction with exercise intervention

    Self-developed questionnaire

    Measured: 0-9 months

  24. Biomarkers (systemic inflammation, growth factors, blood/brain barrier modulators)

    Blood samples (plasma, serum, buffy coat and peripheral blood mononuclear cells (PBMC) )

    Measured: 0-6 months

  25. Disease control

    Progress or disease control of the breast cancer will be derived from medical records and/or the cancer registry

    Measured: 0-9 months

  26. Cancer treatment

    The type and duration of cancer treatment during the study will be derived from medical records and/or the cancer registry

    Measured: 0-9 months

  27. Quality of working life

    QWLQ-CS (add-on in several centers)

    Measured: 0-9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Oct 2019
  2. Study start8 Jan 2020
  3. Primary completion28 Feb 2023
  4. Study completion1 Jul 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
357 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04120298
Sponsor's protocol ID
19-524
Other IDs
NL69600.041.19
Acronym
EFFECT
Status last verified
May 2026
First submitted
12 Sep 2019
Last updated
11 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zopf 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.

    PubMed 41975453

  • 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.

    PubMed 40714912

  • 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.

    PubMed 39805062

  • 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.

    PubMed 39054374

  • 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.

    PubMed 37170950

  • 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.

    PubMed 35906659

Questions about this trial

What is this clinical trial studying?

A study testing Supervised exercise in people with Metastatic Breast Cancer, run by UMC Utrecht at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cancer-related physical fatigue (time frame: 0- 6 months (measured at baseline, 3 and 6 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04120298, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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