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Trial record 1 of 1 for:    NCT04120298
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Effects of Exercise in Patients With Metastatic Breast Cancer (EFFECT)

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ClinicalTrials.gov Identifier: NCT04120298
Recruitment Status : Not yet recruiting
First Posted : October 9, 2019
Last Update Posted : October 9, 2019
Sponsor:
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
Information provided by (Responsible Party):
Dr. Anne May, 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).

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Behavioral: Supervised exercise Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Structured and Individualized Exercise in Patients With Metastatic Breast Cancer on Fatigue and Quality of Life
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : July 1, 2027

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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

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.



Primary Outcome Measures :
  1. Cancer-related physical fatigue [ Time Frame: 0- 6 months (measured at baseline, 3 and 6 months) ]
    Physical fatigue measured with the EORTC QLQ-FA12

  2. Health-related Quality of Life [ Time Frame: 0- 6 months (measured at baseline, 3 and 6 months) ]
    Disease specific HRQoL measured with the EORTC QLQ-C30 Summary Score


Secondary Outcome Measures :
  1. Separate HRQoL domains and Summary Score [ Time Frame: 0-9 months ]
    EORTC QLQ-C30 function and symptom scores scores

  2. Cancer-related fatigue [ Time Frame: 0-9 months ]
    EORTC QLQ-FA12 scores

  3. Breast cancer specific symptoms [ Time Frame: 0-9 months ]
    EORTC QLQ-BR45

  4. Anxiety, depression [ Time Frame: 0-9 months ]
    PHQ-4

  5. Sleep [ Time Frame: 0-9 months ]
    PSQI

  6. Pain: severity and its impact on functioning. [ Time Frame: 0-9 months ]
    BPI

  7. Neuropathic pain [ Time Frame: 0-9 months ]
    painDETECT

  8. Pain Catastrophizing [ Time Frame: 0-9 months ]
    PCS

  9. Treatment-related toxicities grade≥3 [ Time Frame: 0-9 months ]
    Common Toxicity Criteria for adverse events (CTCAE)

  10. Weight [ Time Frame: 0-6 months ]
    weight measured in KG

  11. Height [ Time Frame: 0-6 months ]
    Height measured in meters

  12. Waist circumference [ Time Frame: 0-6 months ]
    waist circumference measured in cm

  13. Body composition (fat free mass and fat mass) [ Time Frame: 0-6 months ]
    Bioelectrical impedance analysis (BIA), add-on (not obligatory): DEXA

  14. Physical activity (subjective) [ Time Frame: 0-6-9 months ]
    Questionnaire

  15. Physical activity (objective) [ Time Frame: 0-6-9 months ]
    activity tracker

  16. Resting heart rate [ Time Frame: 0-6 months ]
    Resting heart rate

  17. Blood pressure [ Time Frame: 0-6 months ]
    Blood pressure (diastolic and systolic) measured at rest

  18. Physical performance [ Time Frame: 0-6 months ]
    Short Physical Performance Battery, handgrip- and leg strength test

  19. Physical fitness [ Time Frame: 0-6 months ]
    Steep ramp test and endurance cycle test, add-on (not obligatory): CPET

  20. Work status/ healthcare resources consumption [ Time Frame: 0-9 months ]
    iPCQ/iMCQ

  21. Intervention costs [ Time Frame: 0-9 months ]
    Cost analyses

  22. Health status [ Time Frame: 0-9 months ]
    EQ-5D-5L

  23. Satisfaction with exercise intervention [ Time Frame: 0-9 months ]
    Self-developed questionnaire

  24. Biomarkers (systemic inflammation, growth factors, blood/brain barrier modulators) [ Time Frame: 0-6 months ]
    Blood samples (plasma, serum, buffy coat and peripheral blood mononuclear cells (PBMC) )

  25. Disease control [ Time Frame: 0-9 months ]
    Progress or disease control of the breast cancer will be derived from medical records and/or the cancer registry

  26. Cancer treatment [ Time Frame: 0-9 months ]
    The type and duration of cancer treatment during the study will be derived from medical records and/or the cancer registry


Other Outcome Measures:
  1. Overall and breast-cancer specific survival [ Time Frame: 0-60 months ]
    Exploratory outcome

  2. Progression-free survival [ Time Frame: 0-60 months ]
    Exploratory outcome

  3. Safety of exercise intervention [ Time Frame: 0-9 months ]
    (Serious) Adverse events potentially related to the exercise intervention



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04120298


Contacts
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Contact: Anne May, PhD 0031-88-7551132 a.m.may@umcutrecht.nl
Contact: Evelyn Monninkhof, PhD 0031-88-7559379 e.monninkhof@umcutrecht.nl

Sponsors and Collaborators
UMC Utrecht
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
Investigators
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Principal Investigator: Anne May, PhD UMC Utrecht Julius Center
Additional Information:
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Responsible Party: Dr. Anne May, Cancer Epidemiologist, UMC Utrecht
ClinicalTrials.gov Identifier: NCT04120298    
Other Study ID Numbers: 19-524
NL69600.041.19 ( Other Identifier: CCMO )
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Anne May, UMC Utrecht:
exercise
cancer-related fatigue
quality of life
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases