search
Back to results

Effects of Exercise in Patients With Metastatic Breast Cancer (EFFECT)

Primary Purpose

Metastatic Breast Cancer

Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Supervised exercise
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Metastatic Breast Cancer focused on measuring exercise, cancer-related fatigue, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Medical Center Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Supervised exercise group

Control group

Arm 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

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.

Outcomes

Primary Outcome Measures

Cancer-related physical fatigue
Physical fatigue measured with the EORTC QLQ-FA12
Health-related Quality of Life
Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score

Secondary Outcome Measures

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

Full Information

First Posted
September 12, 2019
Last Updated
May 9, 2023
Sponsor
UMC Utrecht
Collaborators
German Cancer Research Center, Australian Catholic University, Karolinska Institutet, The Netherlands Cancer Institute, Medical University of Gdansk, Fundación Onkologikoa Fundazioa, Europa Donna, German Sport University, Cologne, University Hospital Heidelberg, Nurogames GmbH, Cologne
search

1. Study Identification

Unique Protocol Identification Number
NCT04120298
Brief Title
Effects of Exercise in Patients With Metastatic Breast Cancer
Acronym
EFFECT
Official Title
Effects of Structured and Individualized Exercise in Patients With Metastatic Breast Cancer on Fatigue and Quality of Life
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 8, 2020 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UMC Utrecht
Collaborators
German Cancer Research Center, Australian Catholic University, Karolinska Institutet, The Netherlands Cancer Institute, Medical University of Gdansk, Fundación Onkologikoa Fundazioa, Europa Donna, German Sport University, Cologne, University Hospital Heidelberg, Nurogames GmbH, Cologne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
exercise, cancer-related fatigue, quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
357 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised exercise group
Arm Type
Experimental
Arm 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
Arm Title
Control group
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Supervised exercise
Intervention Description
An individualised exercise programme supervised by a trained instructor
Primary Outcome Measure Information:
Title
Cancer-related physical fatigue
Description
Physical fatigue measured with the EORTC QLQ-FA12
Time Frame
0- 6 months (measured at baseline, 3 and 6 months)
Title
Health-related Quality of Life
Description
Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score
Time Frame
0- 6 months (measured at baseline, 3 and 6 months)
Secondary Outcome Measure Information:
Title
Separate HRQoL domains and Summary Score
Description
EORTC QLQ-C30 function and symptom scores scores
Time Frame
0-9 months
Title
Cancer-related fatigue
Description
EORTC QLQ-FA12 scores
Time Frame
0-9 months
Title
Breast cancer specific symptoms
Description
EORTC QLQ-BR45
Time Frame
0-9 months
Title
Anxiety, depression
Description
PHQ-4
Time Frame
0-9 months
Title
Sleep
Description
PSQI
Time Frame
0-9 months
Title
Pain: severity and its impact on functioning.
Description
BPI
Time Frame
0-9 months
Title
Neuropathic pain
Description
painDETECT
Time Frame
0-9 months
Title
Pain Catastrophizing
Description
PCS
Time Frame
0-9 months
Title
Treatment-related toxicities grade≥3
Description
Common Toxicity Criteria for adverse events (CTCAE)
Time Frame
0-9 months
Title
Weight
Description
weight measured in KG
Time Frame
0-6 months
Title
Height
Description
Height measured in meters
Time Frame
0-6 months
Title
Waist circumference
Description
waist circumference measured in cm
Time Frame
0-6 months
Title
Body composition (fat free mass and fat mass)
Description
Bioelectrical impedance analysis (BIA), add-on in some centers (not obligatory): DEXA
Time Frame
0-6 months
Title
Physical activity (subjective)
Description
Questionnaire
Time Frame
0-6-9 months
Title
Physical activity (objective)
Description
activity tracker
Time Frame
0-6-9 months
Title
Resting heart rate
Description
Resting heart rate
Time Frame
0-6 months
Title
Blood pressure
Description
Blood pressure (diastolic and systolic) measured at rest
Time Frame
0-6 months
Title
Physical performance
Description
Short Physical Performance Battery, handgrip- and leg strength test
Time Frame
0-6 months
Title
Physical fitness
Description
Steep ramp test and endurance cycle test, add-on (not obligatory): CPET
Time Frame
0-6 months
Title
Work status/ healthcare resources consumption
Description
iPCQ/iMCQ
Time Frame
0-9 months
Title
Intervention costs
Description
Cost analyses
Time Frame
0-9 months
Title
Health status
Description
EQ-5D-5L
Time Frame
0-9 months
Title
Satisfaction with exercise intervention
Description
Self-developed questionnaire
Time Frame
0-9 months
Title
Biomarkers (systemic inflammation, growth factors, blood/brain barrier modulators)
Description
Blood samples (plasma, serum, buffy coat and peripheral blood mononuclear cells (PBMC) )
Time Frame
0-6 months
Title
Disease control
Description
Progress or disease control of the breast cancer will be derived from medical records and/or the cancer registry
Time Frame
0-9 months
Title
Cancer treatment
Description
The type and duration of cancer treatment during the study will be derived from medical records and/or the cancer registry
Time Frame
0-9 months
Title
Quality of working life
Description
QWLQ-CS (add-on in several centers)
Time Frame
0-9 months
Other Pre-specified Outcome Measures:
Title
Overall and breast-cancer specific survival
Description
Exploratory outcome
Time Frame
0-60 months
Title
Progression-free survival
Description
Exploratory outcome
Time Frame
0-60 months
Title
Safety of exercise intervention
Description
(Serious) Adverse events potentially related to the exercise intervention
Time Frame
0-9 months
Title
Urinary incontinence
Description
Exploratory outcome (add on in some centers) - measured with ICIQ-UI
Time Frame
0-9 months
Title
Maximal isokinetic and isometric leg strength, muscle thickness of m. rectus femoris (RF) and m. vastus lateralis (VL)
Description
Exploratory outcome (add on in one center) - Isokinetic and isometric legstrength measured with peak torque / Muscle thickness with ultrasound protocol
Time Frame
0-9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne May, PhD
Organizational Affiliation
UMC Utrecht Julius Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35906659
Citation
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.
Results Reference
derived
Links:
URL
https://www.h2020preferable.eu/
Description
Website of the EFFECT study within the PREFERABLE project
URL
https://twitter.com/PREFERABLE_MBC
Description
Twitter account PREFERABLE project

Learn more about this trial

Effects of Exercise in Patients With Metastatic Breast Cancer

We'll reach out to this number within 24 hrs