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Completed

NCT Number: NCT04307407

Exercise in Breast Cancer Survivors

The purpose of this study is to compare the effects of aerobic exercise to usual care in women treated with chemotherapy and radiation therapy for non-metastatic breast cancer

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Key information

Age range

28 year–72 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Norwegian School of Sport Sciences

Oslo, 0806, Norway

About this study

In this study, we will compare the effects of exercise between women previously treated with breast cancer to women with no history of any cancers. Therefore, in addition to a randomized controlled trial in women with previous breast cancer (i.e., an exerciser group and a control group), we also include a reference group comprising age-matched women with no history of any cancer diagnosis. Women in the reference group will undergo a similar exercise intervention and the exercise group. This study recruits through invitation only.

The primary endpoint in this study is the change in cardiorespiratory fitness, measured as VO2peak. Secondary endpoints include common risk factors for cardiovascular disease and cardiometabolic health, endpoints derived from the cardiopulmonary exercise test and lung function assessments, cellular muscle endpoints derived from muscle biopsies obtained from m. vastus lateralis, also patient-reported outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Eligible BCS must be listed in the Norwegian Cancer registry
  • Female
  • Adult-onset breast cancer diagnosis, diagnosed between 2008 and 2012
  • 60 years or younger at the time of diagnosis
  • received anthracycline-based chemotherapy as a part of their treatment history
  • signed informed consent and medical doctors approveal of participation prior to inclusion

Exclusion criteria

  • Received Herceptin
  • Diagnosed with stage IV breast cancer
  • Relapse since diagnosis
  • A history, or current presence, of another diagnosis of invasive cancer of any kind
  • Selfreported severe fatigue
  • present with any uncontrolled- or recent cardiovascular disease, has undergone heart surgery or uses a pacemaker
  • currently exercising more than 90 minutes per week

Treatment and study plan

Aerobic Exercise

Behavioral

Participants will be randomized to supervised aerobic exercise or standard care. Women with no current or past malignant disease will comprise the reference group and will be matched for age to participants in the Aerobic Exercise arm

Primary outcomes

  1. Change in VO2peak

    Time frame: From baseline to five months (post-intervention)

    Peak oxygen uptake during a treadmill based cardiopulmonary exercise test

Secondary outcomes

  1. Systolic- and diastolic heart chamber dimensions

    Time frame: From baseline to five months (post-intervention)

    Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography

  2. Systolic- and diastolic longitudinal strain

    Time frame: From baseline to five months (post-intervention)

    Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography

  3. Lean body mass

    Time frame: From baseline to five months (post-intervention)

    Body composition will be assessed by dual x-ray absorptiometry

  4. Fat mass

    Time frame: From baseline to five months (post-intervention)

    Body composition will be assessed by dual x-ray absorptiometry

  5. Blood volume

    Time frame: From baseline to five months (post-intervention)

    Hemoglobin mass and blood volume will be assessed using the carbon monoxide rebreathing method

  6. Muscle fiber type

    Time frame: From baseline to five months (post-intervention)

    Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry

  7. Muscle fiber area

    Time frame: From baseline to five months (post-intervention)

    Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry

  8. Muscle mitochondria mass

    Time frame: From baseline to five months (post-intervention)

    Change in mitochondrial proteins will be assessed in muscle biopsies using western blot

  9. Quality of life: Quality of Life Questionnaire (QLQ) C-30

    Time frame: From baseline to five months (post-intervention)

    Relevant patient reported outcomes will be obtained using validated Quality of Life Questionnaire (QLQ) C-30

  10. Genome-wide DNA methylation and gene expression

    Time frame: From baseline to five months (post-intervention)

    For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA

Sponsors and collaborators

Lead sponsor

Norwegian School of Sport Sciences

Other

Collaborators

  • Memorial Sloan Kettering Cancer Center
  • Oslo University Hospital
  • University of Oslo

Registry information

Official study title

The Cause Trial: A Randomized Trial of Aerobic Exercise on CVD Risk Factors in Breast Cancer Survivors

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Mar 13, 2020
Registry last updated
Mar 3, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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