Effects of Exercise in Patients With Metastatic Breast Cancer

Metastatic Breast Cancer Clinical Trial

— EFFECT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04120298
• Other study ID #: 19-524
• Secondary ID: NL69600.041.19
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 8, 2020
• Est. completion date: July 1, 2027

Study information

• Verified date: December 2023
• Source: UMC Utrecht
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 357
• Est. completion date: July 1, 2027
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Metastatic Breast Cancer

Intervention

Behavioral:
• Supervised exercise
An individualised exercise programme supervised by a trained instructor

Locations

Country	Name	City	State
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (11)

Lead Sponsor	Collaborator
UMC Utrecht	Australian Catholic University, Europa Donna, Fundación Onkologikoa Fundazioa, German Cancer Research Center, German Sport University, Cologne, Karolinska Institutet, Medical University of Gdansk, Nurogames GmbH, Cologne, The Netherlands Cancer Institute, University Hospital Heidelberg

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Overall and breast-cancer specific survival	Exploratory outcome	0-60 months
Other	Progression-free survival	Exploratory outcome	0-60 months
Other	Safety of exercise intervention	(Serious) Adverse events potentially related to the exercise intervention	0-9 months
Other	Urinary incontinence	Exploratory outcome (add on in some centers) - measured with ICIQ-UI	0-9 months
Other	Maximal isokinetic and isometric leg strength, muscle thickness of m. rectus femoris (RF) and m. vastus lateralis (VL)	Exploratory outcome (add on in one center) - Isokinetic and isometric legstrength measured with peak torque / Muscle thickness with ultrasound protocol	0-9 months
Primary	Cancer-related physical fatigue	Physical fatigue measured with the EORTC QLQ-FA12	0- 6 months (measured at baseline, 3 and 6 months)
Primary	Health-related Quality of Life	Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score	0- 6 months (measured at baseline, 3 and 6 months)
Secondary	Separate HRQoL domains and Summary Score	EORTC QLQ-C30 function and symptom scores scores	0-9 months
Secondary	Cancer-related fatigue	EORTC QLQ-FA12 scores	0-9 months
Secondary	Breast cancer specific symptoms	EORTC QLQ-BR45	0-9 months
Secondary	Anxiety, depression	PHQ-4	0-9 months
Secondary	Sleep	PSQI	0-9 months
Secondary	Pain: severity and its impact on functioning.	BPI	0-9 months
Secondary	Neuropathic pain	painDETECT	0-9 months
Secondary	Pain Catastrophizing	PCS	0-9 months
Secondary	Treatment-related toxicities grade=3	Common Toxicity Criteria for adverse events (CTCAE)	0-9 months
Secondary	Weight	weight measured in KG	0-6 months
Secondary	Height	Height measured in meters	0-6 months
Secondary	Waist circumference	waist circumference measured in cm	0-6 months
Secondary	Body composition (fat free mass and fat mass)	Bioelectrical impedance analysis (BIA), add-on in some centers (not obligatory): DEXA	0-6 months
Secondary	Physical activity (subjective)	Questionnaire	0-6-9 months
Secondary	Physical activity (objective)	activity tracker	0-6-9 months
Secondary	Resting heart rate	Resting heart rate	0-6 months
Secondary	Blood pressure	Blood pressure (diastolic and systolic) measured at rest	0-6 months
Secondary	Physical performance	Short Physical Performance Battery, handgrip- and leg strength test	0-6 months
Secondary	Physical fitness	Steep ramp test and endurance cycle test, add-on (not obligatory): CPET	0-6 months
Secondary	Work status/ healthcare resources consumption	iPCQ/iMCQ	0-9 months
Secondary	Intervention costs	Cost analyses	0-9 months
Secondary	Health status	EQ-5D-5L	0-9 months
Secondary	Satisfaction with exercise intervention	Self-developed questionnaire	0-9 months
Secondary	Biomarkers (systemic inflammation, growth factors, blood/brain barrier modulators)	Blood samples (plasma, serum, buffy coat and peripheral blood mononuclear cells (PBMC) )	0-6 months
Secondary	Disease control	Progress or disease control of the breast cancer will be derived from medical records and/or the cancer registry	0-9 months
Secondary	Cancer treatment	The type and duration of cancer treatment during the study will be derived from medical records and/or the cancer registry	0-9 months
Secondary	Quality of working life	QWLQ-CS (add-on in several centers)	0-9 months

External Links

•   Twitter account PREFERABLE project
•   Website of the EFFECT study within the PREFERABLE project