Exercise Training in Postmenopausal Patients With Breast Cancer

Physical Activity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384838
• Other study ID #: AGMT_BC_Sports
• Status: Completed
• Phase: N/A
• First received: June 28, 2011
• Last updated: June 3, 2015
• Start date: June 2011
• Est. completion date: April 2015

Study information

• Verified date: June 2015
• Source: Arbeitsgemeinschaft medikamentoese Tumortherapie
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research

Related Conditions & MeSH terms

• Physical Activity

Intervention

Behavioral:
• Counseling
Nutritional, lifestyle and sports counseling
• physical activity
counseling and controlled physical activity

Locations

Country	Name	City	State
Austria	Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum	Salzburg

Sponsors (2)

Lead Sponsor	Collaborator
Arbeitsgemeinschaft medikamentoese Tumortherapie	Roche Pharma AG

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity.		after 6 months	No
Secondary	Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis		after 6 and 12 months	No
Secondary	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	No