Randomized Trial of Exercise Training in Postmenopausal Patients With Hormone-receptor Positive Breast Cancer Undergoing Treatment With Aromatase Inhibitors
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Physical Activity
- Sponsor
- Arbeitsgemeinschaft medikamentoese Tumortherapie
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity.
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief Summary
This randomized trial aims to assess if a well defined subgroup of breast cancer patients benefit from a controlled physical activity program.
All patients will be screened for their physical ability to complete the interventional exercise program. Only patients capable and willing to take part in this study and meeting all inclusion and exclusion criteria will be randomized.
All patients are to receive identical counseling for ideal nutritional, life-style and physical activity.
Patients randomized to Arm 2 will additionally undergo a controlled and observed program of physical activity for a period of 6 months. Thereafter the patients are expected to adhere to a comparable, unobserved exercise program at home.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed informed consent
- •Postmenopausal women with hormone receptor positive breast cancer (as defined by HR \>= ++ and/or PR \>= ++) who are treated with aromatase inhibitors
- •ECOG performance status \<= 2
- •all age groups
Exclusion Criteria
- •Pathologic ergometry
- •Uncontrolled diabetes mellitus
- •Uncontrolled hypertension
- •COPD \> II
- •Active opportunistic infection
- •NYHA heart failure III or IV
Outcomes
Primary Outcomes
Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity.
Time Frame: after 6 months
Secondary Outcomes
- Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis(after 6 and 12 months)
- Evaluation of the influence of controlled/observed physical activity versus lifestyle counseling only on Fitness level, Quality of Life, rate of infections, weight, body mass index BMI, Body fat percentage(after 6 and 12 months)