Status:
COMPLETED
BREAST CANCER AND EXERCISE
Lead Sponsor:
Finnish Breast Cancer Group
Conditions:
Prevent Osteoporosis and Osteoporotic Fractures
Improve Quality of Life
Eligibility:
FEMALE
35-68 years
Phase:
PHASE3
Brief Summary
A Finnish Breast Cancer Group Study (BREX 01-2004). A multicenter phase III open randomised trial of the efficacy of exercise in the prevention of long-term adverse effects of adjuvant treatments and ...
Detailed Description
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 brea...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2007
Estimated Enrollment :
573 Patients enrolled
Trial Details
Trial ID
NCT00639210
Start Date
September 1 2005
End Date
September 1 2007
Last Update
February 26 2019
Active Locations (1)
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1
Helsinki University Central Hospital, Department of Oncology
Helsinki, Finland, 00029