- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00639210
BREAST CANCER AND EXERCISE (BREX)
BREAST CANCER AND EXERCISE BREX: A Multicenter Phase III Open Randomised Trial of the Efficacy of Exercise in the Prevention of Long-term Adverse Effects of Adjuvant Treatments and Breast Cancer Recurrences in Women With Primary Breast Cancer.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Helsinki, Finland, 00029
- Helsinki University Central Hospital, Department of Oncology
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria: Histologically proven invasive breast cancer T1-4N0-3M0, pre- or postmenopausal breast cancer patient treated with adjuvant chemotherapy or radiotherapy within 4 months or patient who has started adjuvant endocrine therapy (antiestrogens, aromatase inhibitors, LHRH agonists, or combinations) no later than 4 months earlier,age from 35 to 68 years,signed informed consent prior to beginning protocol specific procedures
Exclusion Criteria:
- Prior malignancy except basal cell carcinoma or in situ cervix carcinoma
- Male gender
- Haematogenous metastases (M1)
- No systemic adjuvant therapy
- Postmenopausal women treated with antiestrogens, tamoxifen or toremifene, adjuvant treatment only (+/- radiotherapy)
- Pregnancy or recent lactation (< 1 year)
- Severe cardiac disease (New York Heart Association class III or greater), myocardial infarction within 12 months, uncontrolled hypertension
- Verified osteoporosis (proximal femur or lumbar spine t-score < -2.5 or fracture without trauma)
- Concomitant medications affecting calcium and bone metabolism such as bisphosphonates, calcitonin, PTH, SERMs, oral corticosteroids (over 6 months), anticonvulsants (fenytoin, carbamazepine) and prolonged heparin therapy
- Other diseases affecting calcium and bone metabolism such as hyperthyroidism, newly diagnosed hypothyroidism, primary hyperparathyroidism, renal failure, chronic hepatic diseases, organ transplant, Cushing's syndrome, rheumatoid arthritis, chronic bowel diseases such as celiac disease, Chron disease or history of total ventricular resection
- Other serious illness or medical condition, which could be contraindication for exercise
- Patients not capable of training (severe knee arthrosis, severe ligamental or cartilage injuries at lower extremities)
- Residence more than one hour from the exercise centre
- Competitive athlete
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: B
|
|
Other: A
Supervised training is organised for the exercise group once a week in groups of 10 to 15 subjects.
The training is guided by an experienced physical therapist.
|
Design: supervised training is organised for the exercise group once a week in groups of 10 to 15 subjects.
The training is guided by an experienced physical therapist.Content:
The supervised training of the exercise group consists of two different classes alternating at four week periods; step aerobics class and circuit training class.
The 60-minute aerobics and circuit training classes also include warming-up and cooling-down periods both lasting 10-15 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The aim of the study is to investigate whether regular exercise after adjuvant treatments of breast cancer could prevent osteoporosis and improve quality of life.
Time Frame: 1-10 years
|
1-10 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Fitness and weight control, number of falls and fractures, breast cancer recurrence.
Time Frame: 1-10 years
|
1-10 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tiina Saarto, MD, PhD, Helsinki University Central Hospital, Department of Oncology
Publications and helpful links
General Publications
- Poikonen-Saksela P, Kolokotroni E, Vehmanen L, Mattson J, Stamatakos G, Huovinen R, Kellokumpu-Lehtinen PL, Blomqvist C, Saarto T. A graphical LASSO analysis of global quality of life, sub scales of the EORTC QLQ-C30 instrument and depression in early breast cancer. Sci Rep. 2022 Feb 8;12(1):2112. doi: 10.1038/s41598-022-06138-2.
- Penttinen HM, Saarto T, Kellokumpu-Lehtinen P, Blomqvist C, Huovinen R, Kautiainen H, Jarvenpaa S, Nikander R, Idman I, Luoto R, Sievanen H, Utriainen M, Vehmanen L, Jaaskelainen AS, Elme A, Ruohola J, Luoma M, Hakamies-Blomqvist L. Quality of life and physical performance and activity of breast cancer patients after adjuvant treatments. Psychooncology. 2011 Nov;20(11):1211-20. doi: 10.1002/pon.1837. Epub 2010 Sep 27.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Protocol number FBCSG-01-2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Improve Quality of Life
-
Istituto Ortopedico RizzoliUniversity of BolognaRecruitingImprove Quality of LifeItaly
-
Hôpital CochinUnknown
-
Happy Nation SocietyCompleted
-
Kaohsiung Medical University Chung-Ho Memorial...UnknownTo Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRTTaiwan
-
Assiut UniversityCompletedHeavy Menstrual Bleeding | Improve Quality of LifeEgypt
-
B. Braun Medical SAUnknownQuality of Life of Colostomized Patient
-
Children's National Research InstituteRecruitingProfessional Quality of LifeUnited States
-
Assiut UniversityUnknownImproving Quality of LifeEgypt
-
Mattu UniversityCompletedBreif Description: Patients' Quality of Life ofEthiopia
-
Region VästmanlandUnknownHealth Related Quality of Life
Clinical Trials on supervised training
-
University of ManchesterUnknownCardiovascular Diseases | Peripheral Arterial Disease
-
Julius-Maximilians UniversityHannover Medical School; Goethe University; Triemli Hospital; Mukoviszidose eV... and other collaboratorsCompletedCystic FibrosisGermany, Switzerland
-
Medical University of ViennaUnknownPeripheral Artery DiseaseAustria
-
German Cancer Research CenterUniversity Hospital Heidelberg; National Center for Tumor Diseases, HeidelbergCompletedBreast Cancer | Cancer-related FatigueGermany
-
German Cancer Research CenterUniversity Hospital Heidelberg; Central Institute of Mental Health, Mannheim; National Center for Tumor Diseases, HeidelbergCompletedBreast Cancer | Cancer-related FatigueGermany
-
Sheba Medical CenterCompleted
-
University of WaterlooUniversity Health Network, Toronto; Canadian Institutes of Health Research... and other collaboratorsRecruiting
-
Fundación para la Investigación del Hospital Clínico...RecruitingHeart Failure With Preserved Ejection Fraction | Chronotropic IncompetenceSpain
-
University of AarhusOslo University Hospital; Tampere University Hospital; Regionshospitalet Viborg...CompletedProximal Humeral FractureNorway, Denmark
-
Chang Gung Memorial HospitalCompleted