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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.


Phase 3
35 Years
68 Years
Not Enrolling
Female
Prevent Osteoporosis and Osteoporotic Fractures, Improve Quality of Life, Improve Weight Control, and Muscular and Cardiovascular Fitness, Help the Patients to Return to Working Life, Reduce the Risk of Breast Cancer Recurrence, Prevent Other Diseases and Reduce All-Cause Mortality in Patients With Primary Breast Cancer.

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Trial Information

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.


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

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.

Outcome Time Frame:

1-10 years

Safety Issue:

Yes

Principal Investigator

Tiina Saarto, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Helsinki University Central Hospital, Department of Oncology

Authority:

Finland: The Ethical Committee of Helsinki University (non-drug study)

Study ID:

Protocol number FBCSG-01-2004

NCT ID:

NCT00639210

Start Date:

September 2005

Completion Date:

September 2007

Related Keywords:

  • Prevent Osteoporosis and Osteoporotic Fractures
  • Improve Quality of Life
  • Improve Weight Control, and Muscular and Cardiovascular Fitness
  • Help the Patients to Return to Working Life
  • Reduce the Risk of Breast Cancer Recurrence
  • Prevent Other Diseases and Reduce All-Cause Mortality in Patients With Primary Breast Cancer.
  • breast cancer
  • exercise
  • osteoporosis
  • fracture
  • quality of life
  • Breast Neoplasms
  • Fractures, Bone
  • Osteoporosis
  • Recurrence
  • Osteoporotic Fractures

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