NCT01384838

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

June 28, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

June 4, 2015

Status Verified

June 1, 2015

Enrollment Period

3.5 years

First QC Date

June 28, 2011

Last Update Submit

June 3, 2015

Conditions

Physical Activity

Keywords

breast cancerphysical activitysportsexercise

Outcome Measures

Primary Outcomes (1)

  • Individual maximum power output in watt (Pmax) on a bicycle ergometer after 6 months of controlled or unobserved physical activity.

    after 6 months

Secondary Outcomes (2)

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

    after 6 and 12 months

  • 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

    after 6 and 12 months

Study Arms (2)

Counseling

OTHER

Patients are to receive identical counseling for ideal nutritional, lifestyle, physical activity.

Behavioral: Counseling

Controlled physical activity

EXPERIMENTAL

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

Interventions

CounselingBEHAVIORAL

Nutritional, lifestyle and sports counseling

Counseling
physical activityBEHAVIORAL

counseling and controlled physical activity

Controlled physical activity

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Pathologic ergometry
  • Uncontrolled diabetes mellitus
  • Uncontrolled hypertension
  • COPD \> II
  • Active opportunistic infection
  • NYHA heart failure III or IV

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Salzburg, 5020, Austria

Location

Related Publications (1)

  • 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.

    PMID: 30415507DERIVED

MeSH Terms

Conditions

Motor ActivityBreast Neoplasms

Interventions

CounselingExercise

Condition Hierarchy (Ancestors)

BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mental Health ServicesBehavioral Disciplines and ActivitiesCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Richard Greil, Prof.Dr.

    Arbeitsgemeinschaft medikamentoese Tumortherapie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 28, 2011

First Posted

June 29, 2011

Study Start

June 1, 2011

Primary Completion

December 1, 2014

Study Completion

April 1, 2015

Last Updated

June 4, 2015

Record last verified: 2015-06

Locations

AU(1)