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.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 573
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 68 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: supervised training (Other)
B
结局指标
主要结局
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.
时间窗: 1-10 years
次要结局
- Fitness and weight control, number of falls and fractures, breast cancer recurrence.(1-10 years)