BREAST CANCER AND EXERCISE (NCT00639210) | Clinical Trial Compass
CompletedPhase 3
BREAST CANCER AND EXERCISE
Finland573 participantsStarted 2005-09
Plain-language 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 breast cancer recurrences in women with primary breast cancer. The aim of the study is to investigate whether regular exercise training could reduce the long-term side effects of adjuvant treatments of primary breast cancer and improve quality of life and well being.
Who can participate
Age range35 Years – 68 Years
SexFEMALE
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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 di…
What they're measuring
1
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.