Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
  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:


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: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384838

Locations
Austria
Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum
Salzburg, Austria, 5020
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: September 9, 2014
Health Authority: Austria: Ethikkommission

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014