BREAST CANCER AND EXERCISE

Phase 3

Completed

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

• Registration Number: NCT00639210
• Lead Sponsor: Finnish Breast Cancer Group

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 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.

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 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.

Study Timeline

• Study Start: 2005-09
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2008-03-14
• Study First Submitted QC: 2008-03-19
• Study First Posted: 2008-03-20
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-24
• Last Update Posted: 2019-02-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 573

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
A	supervised training	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.

Primary Outcome Measures

Name	Time	Method
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.	1-10 years

Secondary Outcome Measures

Name	Time	Method
Fitness and weight control, number of falls and fractures, breast cancer recurrence.	1-10 years

Trial Locations

Locations (1)

Helsinki University Central Hospital, Department of Oncology; 🇫🇮 Helsinki, Finland