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BREAST CANCER AND EXERCISE (BREX)

This study has been completed.
Sponsor:
Information provided by:
Finnish Breast Cancer Group
ClinicalTrials.gov Identifier:
NCT00639210
First received: March 14, 2008
Last updated: March 19, 2008
Last verified: March 2008

March 14, 2008
March 19, 2008
September 2005
September 2007   (final data collection date for primary 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. [ Time Frame: 1-10 years ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00639210 on ClinicalTrials.gov Archive Site
Fitness and weight control, number of falls and fractures, breast cancer recurrence. [ Time Frame: 1-10 years ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
BREAST CANCER AND EXERCISE
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 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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • 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.
Other: supervised training
Design: 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.Content: The supervised training of the exercise group consists of two different classes alternating at four week periods; step aerobics class and circuit training class. The 60-minute aerobics and circuit training classes also include warming-up and cooling-down periods both lasting 10-15 minutes.
  • 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.
    Intervention: Other: supervised training
  • No Intervention: B
Penttinen HM, Saarto T, Kellokumpu-Lehtinen P, Blomqvist C, Huovinen R, Kautiainen H, Järvenpää S, Nikander R, Idman I, Luoto R, Sievänen H, Utriainen M, Vehmanen L, Jääskeläinen AS, Elme A, Ruohola J, Luoma M, Hakamies-Blomqvist L. Quality of life and physical performance and activity of breast cancer patients after adjuvant treatments. Psychooncology. 2011 Nov;20(11):1211-20. doi: 10.1002/pon.1837. Epub 2010 Sep 27.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
573
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Female
35 Years to 68 Years
No
Contact information is only displayed when the study is recruiting subjects
Finland
 
NCT00639210
Protocol number FBCSG-01-2004
Yes
Riikka Huovinen, Finnish Brest Cancer Group
Finnish Breast Cancer Group
Not Provided
Principal Investigator: Tiina Saarto, MD, PhD Helsinki University Central Hospital, Department of Oncology
Finnish Breast Cancer Group
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP