Clinical trial NCT01384838: Exercise Training in Postmenopausal Patients With Breast Cancer
Official title: Randomized Trial of Exercise Training in Postmenopausal Patients With Hormone-receptor Positive Breast Cancer Undergoing Treatment With Aromatase Inhibitors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Keywords: breast cancer
physical activity
sports
exercise
Lead sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2011-06-29
Enrollment: 80
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.


Eligibility 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

Primary outcomes:
measure: Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity.
timeFrame: after 6 months
Secondary outcomes:
measure: Determination of feasibility of achieving 12 MET/week (metabolic units) on an outpatient basis
timeFrame: after 6 and 12 months
measure: 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
timeFrame: after 6 and 12 months
Other outcomes:
Locations:
city: Salzburg
country: Austria
facility: Universitätsklinik für Innere Medizin III mit Hämatologie, internistischer Onkologie, Infektologie, Rheumatologie und Onkologisches Zentrum
Study officials:
affiliation: Arbeitsgemeinschaft medikamentoese Tumortherapie
name: Richard Greil, Prof.Dr.
role: STUDY_DIRECTOR
References:
citation: Westphal T, Rinnerthaler G, Gampenrieder SP, Niebauer J, Thaler J, Pfob M, Fuchs D, Riedmann M, Mayr B, Reich B, Melchardt T, Mlineritsch B, Pleyer L, Greil R. Supervised versus autonomous exercise training in breast cancer patients: A multicenter randomized clinical trial. Cancer Med. 2018 Dec;7(12):5962-5972. doi: 10.1002/cam4.1851. Epub 2018 Nov 10.