Effects of Exercise in Patients With Metastatic Breast Cancer

Conditions

Metastatic Breast Cancer

Keywords

exercise, cancer-related fatigue, quality of life

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 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).

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.

Alina Kias, Martina E. Schmidt, Anouk E. Hiensch, Dorothea Clauss, Evelyn M. Monninkhof et al. (23 authors)

Cancer Medicine2025-07-272 citations

10.1002/cam4.71074

Supervised, structured and individualized exercise in metastatic breast cancer: a randomized controlled trial.

Hiensch AE, Depenbusch J, Schmidt ME, Monninkhof EM, Pelaez M, Clauss D, Gunasekara N, Zimmer P, Belloso J, Trevaskis M, Rundqvist H, Wiskemann J, Müller 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.

2024-07-2534 citations

10.1038/s41591-024-03143-y

Cost-utility analysis of a supervised exercise program for patients with metastatic breast cancer in the PREFERABLE-EFFECT randomized controlled trial (RCT).

Anouk E. Hiensch, Aniek E.M. Schouten, Evelyn M. Monninkhof, Martina E. Schmidt, Dorothea Clauss et al. (20 authors)

Journal of Clinical Oncology2024-06-013 citations

10.1200/jco.2024.42.16_suppl.11121

Abstract GS02-10: Effects of a structured and individualized exercise program on fatigue and health-related quality of life in patients with metastatic breast cancer: the multinational randomized controlled PREFERABLE-EFFECT study

Anne M. May, Anouk E. Hiensch, Johanna Depenbusch, Martina E. Schmidt, Evelyn M. Monninkhof et al. (34 authors)

Cancer Research2024-05-022 citations

10.1158/1538-7445.sabcs23-gs02-10

STRUCTURED EXERCISE IMPROVES FATIGUE AND HEALTH-RELATED QUALITY OF LIFE IN METASTATIC BREAST CANCER PATIENTS: THE MULTINATIONAL RANDOMIZED CONTROLLED PREFERABLE-EFFECT STUDY

Dr Eva Zopf, Dr Anouk E. Hiensch, Dr Johanna Depenbusch, Dr Martina E. Schmidt, Dr Evelyn M. Monninkhof et al. (34 authors)

Journal of Clinical Exercise Physiology2024-05-01

10.31189/2165-7629-13-s2.339

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

Anouk E. Hiensch, Evelyn M. Monninkhof, Martina E. Schmidt, Eva M. Zopf, Kate A. Bolam et al. (24 authors)

Trials2022-07-2933 citations

10.1186/s13063-022-06556-7

Interventions

BEHAVIORALSupervised exercise

An individualised exercise programme supervised by a trained instructor

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

No

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

Design outcomes

Primary

Measure	Time frame	Description
Cancer-related physical fatigue	0- 6 months (measured at baseline, 3 and 6 months)	Physical fatigue measured with the EORTC QLQ-FA12
Health-related Quality of Life	0- 6 months (measured at baseline, 3 and 6 months)	Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score

Secondary

Measure	Time frame	Description
Separate HRQoL domains and Summary Score	0-9 months	EORTC QLQ-C30 function and symptom scores scores
Cancer-related fatigue	0-9 months	EORTC QLQ-FA12 scores
Breast cancer specific symptoms	0-9 months	EORTC QLQ-BR45
Anxiety, depression	0-9 months	PHQ-4
Sleep	0-9 months	PSQI
Pain: severity and its impact on functioning.	0-9 months	BPI
Neuropathic pain	0-9 months	painDETECT
Pain Catastrophizing	0-9 months	PCS
Treatment-related toxicities grade≥3	0-9 months	Common Toxicity Criteria for adverse events (CTCAE)
Weight	0-6 months	weight measured in KG
Height	0-6 months	Height measured in meters
Waist circumference	0-6 months	waist circumference measured in cm
Body composition (fat free mass and fat mass)	0-6 months	Bioelectrical impedance analysis (BIA), add-on in some centers (not obligatory): DEXA
Physical activity (subjective)	0-6-9 months	Questionnaire
Physical activity (objective)	0-6-9 months	activity tracker
Resting heart rate	0-6 months	Resting heart rate
Blood pressure	0-6 months	Blood pressure (diastolic and systolic) measured at rest
Physical performance	0-6 months	Short Physical Performance Battery, handgrip- and leg strength test
Physical fitness	0-6 months	Steep ramp test and endurance cycle test, add-on (not obligatory): CPET
Work status/ healthcare resources consumption	0-9 months	iPCQ/iMCQ
Intervention costs	0-9 months	Cost analyses
Health status	0-9 months	EQ-5D-5L
Satisfaction with exercise intervention	0-9 months	Self-developed questionnaire
Biomarkers (systemic inflammation, growth factors, blood/brain barrier modulators)	0-6 months	Blood samples (plasma, serum, buffy coat and peripheral blood mononuclear cells (PBMC) )
Disease control	0-9 months	Progress or disease control of the breast cancer will be derived from medical records and/or the cancer registry
Cancer treatment	0-9 months	The type and duration of cancer treatment during the study will be derived from medical records and/or the cancer registry
Quality of working life	0-9 months	QWLQ-CS (add-on in several centers)

Countries

Netherlands

Contacts

PRINCIPAL_INVESTIGATORAnne May, PhD

UMC Utrecht Julius Center

Outcome results

None listed