Exercise Training in Postmenopausal Patients With Breast Cancer

Study Overview
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Brief Summary
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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.

Official Title
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Randomized Trial of Exercise Training in Postmenopausal Patients With Hormone-receptor Positive Breast Cancer Undergoing Treatment With Aromatase Inhibitors

Conditions
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Physical Activity

Intervention / Treatment
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* Behavioral: Counseling
* Behavioral: physical activity


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Counseling<br>Patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity. | Behavioral: Counseling<br>* Nutritional, lifestyle and sports counseling<br>|
| Experimental: Controlled physical activity<br>All patients are to receive identical counseling for ideal nutritional, lifestyle, 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. | Behavioral: physical activity<br>* counseling and controlled physical activity<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity. |  | after 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, physical activity, sports, exercise