Text Size

Exercise Training in Postmenopausal Patients With Breast Cancer

This study is currently recruiting participants.
Verified June 2011 by Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by:
Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier:
NCT01384838
First received: June 28, 2011
Last updated: NA
Last verified: June 2011
History: No changes posted
  Purpose

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.


Condition Intervention
Physical Activity
 Behavioral: Counseling
Behavioral: physical activity

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Randomized Trial of Exercise Training in Postmenopausal Patients With Hormone-receptor Positive Breast Cancer Undergoing Treatment With Aromatase Inhibitors

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 80
Study Start Date: June 2011
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Counseling
Patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity.
 Behavioral: Counseling
Nutritional, lifestyle and sports 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.

 Behavioral: physical activity
counseling and controlled physical activity

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01384838

Contacts
Contact: Richard Greil, Prof. Dr. 0662/4482 ext 2879 r.greil@salk.at

Locations
Austria
Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum Recruiting
Salzburg, Austria, 5020
Contact: Richard Greil, Prof. Dr.     0043/662/4482 ext 2879     r.greil@salk.at    
Sponsors and Collaborators
Arbeitsgemeinschaft medikamentoese Tumortherapie
Roche Pharma AG
Investigators
Study Director: Richard Greil, Prof.Dr. Arbeitsgemeinschaft medikamentoese Tumortherapie
  More Information

No publications provided

Responsible Party: Daniela Wolkersdorfer, Arbeitsgemeinschaft medikamentoese Tumortherapie
ClinicalTrials.gov Identifier: NCT01384838     History of Changes
Other Study ID Numbers: AGMT_BC_Sports
Study First Received: June 28, 2011
Last Updated: June 28, 2011
Health Authority: Austria: Ethikkommission

Keywords provided by Arbeitsgemeinschaft medikamentoese Tumortherapie:
breast cancer
physical activity
sports
exercise

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 17, 2013