Exercise in Breast Cancer Survivors

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT04307407
• Lead Sponsor: Norwegian School of Sport Sciences

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.

Study Timeline

• Study First Submitted: 2020-03-06
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-13
• Study Start: 2020-09-08
• Status Verified: 2023-03
• Primary Completion: 2023-03-02
• Study Completion: 2023-03-02
• Last Update Submitted: 2023-03-02
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 210

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in VO2peak	From baseline to five months (post-intervention)	Peak oxygen uptake during a treadmill based cardiopulmonary exercise test

Secondary Outcome Measures

Name	Time	Method
Fat mass	From baseline to five months (post-intervention)	Body composition will be assessed by dual x-ray absorptiometry
Muscle fiber type	From baseline to five months (post-intervention)	Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry
Systolic- and diastolic longitudinal strain	From baseline to five months (post-intervention)	Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography
Lean body mass	From baseline to five months (post-intervention)	Body composition will be assessed by dual x-ray absorptiometry
Systolic- and diastolic heart chamber dimensions	From baseline to five months (post-intervention)	Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography
Muscle fiber area	From baseline to five months (post-intervention)	Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry
Genome-wide DNA methylation and gene expression	From baseline to five months (post-intervention)	For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA
Blood volume	From baseline to five months (post-intervention)	Hemoglobin mass and blood volume will be assessed using the carbon monoxide rebreathing method
Muscle mitochondria mass	From baseline to five months (post-intervention)	Change in mitochondrial proteins will be assessed in muscle biopsies using western blot
Quality of life: Quality of Life Questionnaire (QLQ) C-30	From baseline to five months (post-intervention)	Relevant patient reported outcomes will be obtained using validated Quality of Life Questionnaire (QLQ) C-30

Trial Locations

Locations (1)

Norwegian School of Sport Sciences; 🇳🇴 Oslo, Norway