Clinical trial NCT04307407: Exercise in Breast Cancer Survivors
Official title: The Cause Trial: A Randomized Trial of Aerobic Exercise on CVD Risk Factors in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Norwegian School of Sport Sciences
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Memorial Sloan Kettering Cancer Center
name: University of Oslo
First posted: 2020-03-13
Enrollment: 210
Sex: FEMALE
Minimum age (years): 28
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in VO2peak
timeFrame: From baseline to five months (post-intervention)
Secondary outcomes:
measure: Systolic- and diastolic heart chamber dimensions
timeFrame: From baseline to five months (post-intervention)
measure: Systolic- and diastolic longitudinal strain
timeFrame: From baseline to five months (post-intervention)
measure: Lean body mass
timeFrame: From baseline to five months (post-intervention)
measure: Fat mass
timeFrame: From baseline to five months (post-intervention)
measure: Blood volume
timeFrame: From baseline to five months (post-intervention)
measure: Muscle fiber type
timeFrame: From baseline to five months (post-intervention)
measure: Muscle fiber area
timeFrame: From baseline to five months (post-intervention)
measure: Muscle mitochondria mass
timeFrame: From baseline to five months (post-intervention)
measure: Quality of life: Quality of Life Questionnaire (QLQ) C-30
timeFrame: From baseline to five months (post-intervention)
measure: Genome-wide DNA methylation and gene expression
timeFrame: From baseline to five months (post-intervention)
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Norwegian School of Sport Sciences
Study officials:
affiliation: The Norwegian School of Sport Sciences
name: Tormod S Nilsen, PhD
role: PRINCIPAL_INVESTIGATOR
References: