Exercise in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04307407
• Other study ID #: 2019/1318
• Status: Completed
• Phase: N/A
• Start date: September 8, 2020
• Est. completion date: March 2, 2023

Study information

• Verified date: March 2023
• Source: Norwegian School of Sport Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: March 2, 2023
• Est. primary completion date: March 2, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 28 Years to 72 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
Norway	Norwegian School of Sport Sciences	Oslo

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian School of Sport Sciences	Memorial Sloan Kettering Cancer Center, Oslo University Hospital, University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in VO2peak	Peak oxygen uptake during a treadmill based cardiopulmonary exercise test	From baseline to five months (post-intervention)
Secondary	Systolic- and diastolic heart chamber dimensions	Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography	From baseline to five months (post-intervention)
Secondary	Systolic- and diastolic longitudinal strain	Cardiac morphology and function will be assessed by 2D and 3D Echocardiography and 2D strain echocardiography	From baseline to five months (post-intervention)
Secondary	Lean body mass	Body composition will be assessed by dual x-ray absorptiometry	From baseline to five months (post-intervention)
Secondary	Fat mass	Body composition will be assessed by dual x-ray absorptiometry	From baseline to five months (post-intervention)
Secondary	Blood volume	Hemoglobin mass and blood volume will be assessed using the carbon monoxide rebreathing method	From baseline to five months (post-intervention)
Secondary	Muscle fiber type	Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry	From baseline to five months (post-intervention)
Secondary	Muscle fiber area	Change in muscle morphology will be assessed in muscle biopsies using immunohistochemistry	From baseline to five months (post-intervention)
Secondary	Muscle mitochondria mass	Change in mitochondrial proteins will be assessed in muscle biopsies using western blot	From baseline to five months (post-intervention)
Secondary	Quality of life: Quality of Life Questionnaire (QLQ) C-30	Relevant patient reported outcomes will be obtained using validated Quality of Life Questionnaire (QLQ) C-30	From baseline to five months (post-intervention)
Secondary	Genome-wide DNA methylation and gene expression	For a sub-group of participants, muscle biopsies will be further processed for RNA and DNA	From baseline to five months (post-intervention)