BREAST CANCER AND EXERCISE (BREX)

Finnish Breast Cancer Group

Status and phase: Completed; Phase 3

Conditions: Prevent Osteoporosis and Osteoporotic Fractures; Improve Quality of Life; Reduce the Risk of Breast Cancer Recurrence; Help the Patients to Return to Working Life; Improve Weight Control, and Muscular and Cardiovascular Fitness; Reduce All-cause Mortality in Patients With Primary Breast Cancer

Treatments: Other: supervised training

Study type: Interventional

Funder types: Other

Identifiers

NCT00639210

Protocol number FBCSG-01-2004

Details and patient eligibility

About

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.

Full 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 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. Large controlled prospective studies are needed to confirm the preliminary findings of exercises benefits in cancer patients, and to investigate the type, the frequency, intensity and tolerability of exercise training in cancer patients, before any clinical recommendations can be given. Prevention of osteoporosis, improvement of weight control, and muscular and cardiovascular fitness is been waited. The second aim of the study is to investigate, whether regular exercise training reduces the risk of breast cancer recurrence, prevents other diseases and reduce all-cause mortality and is cost effective in women with primary breast cancer.

Enrollment: 573 patients

Sex: Female

Ages: 35 to 68 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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573 participants in 2 patient groups

A

Other group

Description:

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.

Treatment:

Other: supervised training

B

No Intervention group