Exercise in Breast Cancer Survivors

Norwegian School of Sport Sciences

Status: Completed

Conditions: Breast Cancer

Treatments: Behavioral: Aerobic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT04307407

2019/1318

Details and patient eligibility

About

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

Full 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.

Enrollment: 210 patients

Sex: Female

Ages: 28 to 72 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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210 participants in 3 patient groups

Aerobic Exercise

Experimental group

Description:

The aim is for participants to complete three weekly sessions of supervised aerobic treadmill based exercise for five months. Session duration varies from 20-60 minutes, with exercise intensity ranging from 55-95% of peak heart rate. Maximal exercise capacity (VO2peak and peak heart rate), will be determined by the CPET performed by certified exercise physiologists at baseline.

Treatment:

Behavioral: Aerobic Exercise

Standard care

No Intervention group

Description:

Participants in this arm will not receive any follow-up on exercise during the intervention period.

Reference Group

Other group

Description:

Participants in this arm are age-matched women with no history of any malignant disease, which will undergo similar assessments at baseline and post-intervention and also follow similar exercise intervention as the breast cancer survivors randomized to the Aerobic exercise arm

Treatment:

Behavioral: Aerobic Exercise