Effects of Exercise in Patients With Metastatic Breast Cancer

Not Applicable

Active, not recruiting

• Conditions: Metastatic Breast Cancer
• Interventions: Behavioral: Supervised exercise

• Registration Number: NCT04120298
• Lead Sponsor: UMC Utrecht

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.

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-10-07
• Study First Posted: 2019-10-09
• Study Start: 2020-01-08
• Primary Completion: 2023-02-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-04
• Last Update Posted: 2023-12-06
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 357

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Supervised exercise group	Supervised exercise	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Intervention costs	0-9 months	Cost analyses
Satisfaction with exercise intervention	0-9 months	Self-developed questionnaire
Weight	0-6 months	weight measured in KG
Neuropathic pain	0-9 months	painDETECT
Sleep	0-9 months	PSQI
Physical activity (subjective)	0-6-9 months	Questionnaire
Pain: severity and its impact on functioning.	0-9 months	BPI
Treatment-related toxicities grade≥3	0-9 months	Common Toxicity Criteria for adverse events (CTCAE)
Height	0-6 months	Height measured in meters
Waist circumference	0-6 months	waist circumference measured in cm
Pain Catastrophizing	0-9 months	PCS
Work status/ healthcare resources consumption	0-9 months	iPCQ/iMCQ
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
Physical activity (objective)	0-6-9 months	activity tracker
Body composition (fat free mass and fat mass)	0-6 months	Bioelectrical impedance analysis (BIA), add-on in some centers (not obligatory): DEXA
Resting heart rate	0-6 months	Resting heart rate
Blood pressure	0-6 months	Blood pressure (diastolic and systolic) measured at rest
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)
Health status	0-9 months	EQ-5D-5L
Disease control	0-9 months	Progress or disease control of the breast cancer will be derived from medical records and/or the cancer registry
Biomarkers (systemic inflammation, growth factors, blood/brain barrier modulators)	0-6 months	Blood samples (plasma, serum, buffy coat and peripheral blood mononuclear cells (PBMC) )

Trial Locations

Locations (1)

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands