Exercise Training in Postmenopausal Patients With Breast Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01384838
First received: June 28, 2011
Last updated: September 9, 2014
Last verified: September 2014

June 28, 2011
September 9, 2014
June 2011
December 2014   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01384838 on ClinicalTrials.gov Archive Site
  • Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis [ Time Frame: after 6 and 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Exercise Training in Postmenopausal Patients With Breast Cancer
Randomized Trial of Exercise Training in Postmenopausal Patients With Hormone-receptor Positive Breast Cancer Undergoing Treatment With Aromatase Inhibitors

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Physical Activity
  • Behavioral: Counseling
    Nutritional, lifestyle and sports counseling
  • Behavioral: physical activity
    counseling and controlled physical activity
  • Counseling
    Patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity.
    Intervention: Behavioral: Counseling
  • Experimental: Controlled 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.

    Intervention: Behavioral: physical activity
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
80
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT01384838
AGMT_BC_Sports
No
Daniela Wolkersdorfer, Arbeitsgemeinschaft medikamentoese Tumortherapie
Arbeitsgemeinschaft medikamentoese Tumortherapie
Roche Pharma AG
Study Director: Richard Greil, Prof.Dr. Arbeitsgemeinschaft medikamentoese Tumortherapie
Arbeitsgemeinschaft medikamentoese Tumortherapie
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP