Trials / Completed
CompletedNCT04307407
Exercise in Breast Cancer Survivors
The Cause Trial: A Randomized Trial of Aerobic Exercise on CVD Risk Factors in Breast Cancer Survivors
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 210 (actual)
- Sponsor
- Norwegian School of Sport Sciences · Academic / Other
- Sex
- Female
- Age
- 28 Years – 72 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Aerobic Exercise | 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 |
Timeline
- Start date
- 2020-09-08
- Primary completion
- 2023-03-02
- Completion
- 2023-03-02
- First posted
- 2020-03-13
- Last updated
- 2023-03-03
Locations
1 site across 1 country: Norway
Source: ClinicalTrials.gov record NCT04307407. Inclusion in this directory is not an endorsement.