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Completed

NCT Number: NCT01384838

Exercise Training in Postmenopausal Patients With Breast Cancer

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.

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Key information

Conditions

Physical Activity Behavior Breast Diseases Breast Neoplasms Motor Activity Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum

Salzburg, 5020, Austria

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Counseling

Behavioral

Nutritional, lifestyle and sports counseling

Physical activity

Behavioral

counseling and controlled physical activity

Primary outcomes

  1. 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 outcomes

  1. Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis

    Time frame: after 6 and 12 months

  2. 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

Sponsors and collaborators

Lead sponsor

Arbeitsgemeinschaft medikamentoese Tumortherapie

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Jun 29, 2011
Registry last updated
Jun 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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