Exercise Training in Postmenopausal Patients With Breast Cancer
Primary Purpose
Physical Activity
Status
Completed
Phase
Not Applicable
Locations
Austria
Study Type
Interventional
Intervention
Counseling
physical activity
Sponsored by
About this trial
This is an interventional health services research trial for Physical Activity focused on measuring breast cancer, physical activity, sports, exercise
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
Sites / Locations
- Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Experimental
Arm Label
Counseling
Controlled physical activity
Arm Description
Patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity.
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.
Outcomes
Primary Outcome Measures
Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity.
Secondary Outcome Measures
Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis
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
Full Information
NCT ID
NCT01384838
First Posted
June 28, 2011
Last Updated
June 3, 2015
Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT01384838
Brief Title
Exercise Training in Postmenopausal Patients With Breast Cancer
Official Title
Randomized Trial of Exercise Training in Postmenopausal Patients With Hormone-receptor Positive Breast Cancer Undergoing Treatment With Aromatase Inhibitors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
April 2015 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Arbeitsgemeinschaft medikamentoese Tumortherapie
Collaborators
Roche Pharma AG
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Physical Activity
Keywords
breast cancer, physical activity, sports, exercise
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Counseling
Arm Type
Other
Arm Description
Patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity.
Arm Title
Controlled physical activity
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
Nutritional, lifestyle and sports counseling
Intervention Type
Behavioral
Intervention Name(s)
physical activity
Intervention Description
counseling and controlled physical activity
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis
Time Frame
after 6 and 12 months
Title
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
Time Frame
after 6 and 12 months
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Greil, Prof.Dr.
Organizational Affiliation
Arbeitsgemeinschaft medikamentoese Tumortherapie
Official's Role
Study Director
Facility Information:
Facility Name
Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
12. IPD Sharing Statement
Citations:
PubMed Identifier
30415507
Citation
Westphal T, Rinnerthaler G, Gampenrieder SP, Niebauer J, Thaler J, Pfob M, Fuchs D, Riedmann M, Mayr B, Reich B, Melchardt T, Mlineritsch B, Pleyer L, Greil R. Supervised versus autonomous exercise training in breast cancer patients: A multicenter randomized clinical trial. Cancer Med. 2018 Dec;7(12):5962-5972. doi: 10.1002/cam4.1851. Epub 2018 Nov 10.
Results Reference
derived
Learn more about this trial
Exercise Training in Postmenopausal Patients With Breast Cancer
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