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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04120298


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT04120298
Ethics application status
Date submitted
1/10/2019
Date registered
7/10/2019
Date last updated
7/10/2019

Titles & IDs
Public title
Effects of Exercise in Patients With Metastatic Breast Cancer
Scientific title
Effects of Structured and Individualized Exercise in Patients With Metastatic Breast Cancer on Fatigue and Quality of Life
Secondary ID [1] 0 0
NL69600.041.19
Secondary ID [2] 0 0
19-524
Universal Trial Number (UTN)
Trial acronym
EFFECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Metastatic Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Behaviour - Supervised exercise

Experimental: Supervised exercise group - 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

No Intervention: Control group - 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.


Behaviour: Supervised exercise
An individualised exercise programme supervised by a trained instructor

Intervention code [1] 0 0
Behaviour
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Cancer-related physical fatigue - Physical fatigue measured with the EORTC QLQ-FA12
Timepoint [1] 0 0
0- 6 months (measured at baseline, 3 and 6 months)
Primary outcome [2] 0 0
Health-related Quality of Life - Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score
Timepoint [2] 0 0
0- 6 months (measured at baseline, 3 and 6 months)
Secondary outcome [1] 0 0
Separate HRQoL domains and Summary Score - EORTC QLQ-C30 function and symptom scores scores
Timepoint [1] 0 0
0-9 months
Secondary outcome [2] 0 0
Cancer-related fatigue - EORTC QLQ-FA12 scores
Timepoint [2] 0 0
0-9 months
Secondary outcome [3] 0 0
Breast cancer specific symptoms - EORTC QLQ-BR45
Timepoint [3] 0 0
0-9 months
Secondary outcome [4] 0 0
Anxiety, depression - PHQ-4
Timepoint [4] 0 0
0-9 months
Secondary outcome [5] 0 0
Sleep - PSQI
Timepoint [5] 0 0
0-9 months
Secondary outcome [6] 0 0
Pain: severity and its impact on functioning. - BPI
Timepoint [6] 0 0
0-9 months
Secondary outcome [7] 0 0
Neuropathic pain - painDETECT
Timepoint [7] 0 0
0-9 months
Secondary outcome [8] 0 0
Pain Catastrophizing - PCS
Timepoint [8] 0 0
0-9 months
Secondary outcome [9] 0 0
Treatment-related toxicities grade≥3 - Common Toxicity Criteria for adverse events (CTCAE)
Timepoint [9] 0 0
0-9 months
Secondary outcome [10] 0 0
Weight - weight measured in KG
Timepoint [10] 0 0
0-6 months
Secondary outcome [11] 0 0
Height - Height measured in meters
Timepoint [11] 0 0
0-6 months
Secondary outcome [12] 0 0
Waist circumference - waist circumference measured in cm
Timepoint [12] 0 0
0-6 months
Secondary outcome [13] 0 0
Body composition (fat free mass and fat mass) - Bioelectrical impedance analysis (BIA), add-on (not obligatory): DEXA
Timepoint [13] 0 0
0-6 months
Secondary outcome [14] 0 0
Physical activity (subjective) - Questionnaire
Timepoint [14] 0 0
0-6-9 months
Secondary outcome [15] 0 0
Physical activity (objective) - activity tracker
Timepoint [15] 0 0
0-6-9 months
Secondary outcome [16] 0 0
Resting heart rate - Resting heart rate
Timepoint [16] 0 0
0-6 months
Secondary outcome [17] 0 0
Blood pressure - Blood pressure (diastolic and systolic) measured at rest
Timepoint [17] 0 0
0-6 months
Secondary outcome [18] 0 0
Physical performance - Short Physical Performance Battery, handgrip- and leg strength test
Timepoint [18] 0 0
0-6 months
Secondary outcome [19] 0 0
Physical fitness - Steep ramp test and endurance cycle test, add-on (not obligatory): CPET
Timepoint [19] 0 0
0-6 months
Secondary outcome [20] 0 0
Work status/ healthcare resources consumption - iPCQ/iMCQ
Timepoint [20] 0 0
0-9 months
Secondary outcome [21] 0 0
Intervention costs - Cost analyses
Timepoint [21] 0 0
0-9 months
Secondary outcome [22] 0 0
Health status - EQ-5D-5L
Timepoint [22] 0 0
0-9 months
Secondary outcome [23] 0 0
Satisfaction with exercise intervention - Self-developed questionnaire
Timepoint [23] 0 0
0-9 months
Secondary outcome [24] 0 0
Biomarkers (systemic inflammation, growth factors, blood/brain barrier modulators) - Blood samples (plasma, serum, buffy coat and peripheral blood mononuclear cells (PBMC) )
Timepoint [24] 0 0
0-6 months
Secondary outcome [25] 0 0
Disease control - Progress or disease control of the breast cancer will be derived from medical records and/or the cancer registry
Timepoint [25] 0 0
0-9 months
Secondary outcome [26] 0 0
Cancer treatment - The type and duration of cancer treatment during the study will be derived from medical records and/or the cancer registry
Timepoint [26] 0 0
0-9 months

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Supportive Care
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Primary sponsor type
Other
Name
UMC Utrecht
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
German Cancer Research Center
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Australian Catholic University
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Karolinska Institutet
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
The Netherlands Cancer Institute
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Medical University of Gdansk
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
Fundación Onkologikoa Fundazioa
Address [6] 0 0
Country [6] 0 0
Other collaborator category [7] 0 0
Other
Name [7] 0 0
Europa Donna
Address [7] 0 0
Country [7] 0 0
Other collaborator category [8] 0 0
Other
Name [8] 0 0
German Sport University, Cologne
Address [8] 0 0
Country [8] 0 0
Other collaborator category [9] 0 0
Other
Name [9] 0 0
University Hospital Heidelberg
Address [9] 0 0
Country [9] 0 0
Other collaborator category [10] 0 0
Other
Name [10] 0 0
Nurogames GmbH, Cologne
Address [10] 0 0
Country [10] 0 0

Ethics approval
Ethics application status

Summary
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).
Trial website
https://clinicaltrials.gov/show/NCT04120298
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Anne May, PhD
Address 0 0
UMC Utrecht Julius Center
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Anne May, PhD
Address 0 0
Country 0 0
Phone 0 0
0031-88-7551132
Fax 0 0
Email 0 0
a.m.may@umcutrecht.nl
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT04120298

Additional trial details provided through ANZCTR
Accrual to date
Recruiting in Australia
Recruitment state(s)
VIC
Funding & Sponsors
Primary sponsor
Hospital
Primary sponsor name
University Medical Center Utrecht
Primary sponsor address
University Medical Center Utrecht
Heidelberglaan 100
3584 CX Utrecht
Primary sponsor country
Netherlands
Secondary sponsor category [1] 33
University
Name [1] 33
Australian Catholic University
Address [1] 33
Mary Mackillop Institute for Health Research Australian Catholic University Level 5 215 Spring Street Melbourne VIC 3000
Country [1] 33
Australia
Ethics approval
Ethics application status
Approved
Ethics committee name [1] 15
PETER MACCALLUM CANCER CENTRE HUMAN RESEARCH ETHICS COMMITTEE
Address [1] 15
Peter MacCallum Cancer Centre 305 Grattan Street Melbourne Victoria, 3000
Country [1] 15
Australia
Date submitted for ethics approval [1] 15
29/11/2019
Approval date [1] 15
20/02/2020
Ethics approval number [1] 15
HREC/57626/PMCC-2019
 
Public notes

Contacts
Principal investigator
Title 161 0
Prof
Name 161 0
Anne May
Address 161 0
University Medical Center Utrecht Heidelberglaan 100 3584 CX Utrecht
Country 161 0
Netherlands
Phone 161 0
0031(0)88 755 11 32
Fax 161 0
Email 161 0
A.M.May@umcutrecht.nl
Contact person for public queries
Title 162 0
Dr
Name 162 0
Eva Zopf
Address 162 0
Mary MacKillop Institute for Health Research Australian Catholic University Level 5, 215 Spring Street, Melbourne, VIC 3000
Country 162 0
Australia
Phone 162 0
0392308105
Fax 162 0
Email 162 0
eva.zopf@acu.edu.au
Contact person for scientific queries
Title 163 0
Dr
Name 163 0
Eva Zopf
Address 163 0
Mary MacKillop Institute for Health Research Australian Catholic University Level 5, 215 Spring Street, Melbourne, VIC 3000
Country 163 0
Australia
Phone 163 0
0392308105
Fax 163 0
Email 163 0
eva.zopf@acu.edu.au