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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
History of Changes
  Purpose

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.


Condition Intervention Phase
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
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Finnish Breast Cancer Group:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • Fitness and weight control, number of falls and fractures, breast cancer recurrence. [ Time Frame: 1-10 years ] [ Designated as safety issue: Yes ]

Enrollment: 573
Study Start Date: September 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
 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.
No Intervention: B

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.

  Eligibility

Ages Eligible for Study:   35 Years to 68 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00639210

Locations
Finland
Helsinki University Central Hospital, Department of Oncology
Helsinki, Finland, 00029
Sponsors and Collaborators
Finnish Breast Cancer Group
Investigators
Principal Investigator: Tiina Saarto, MD, PhD Helsinki University Central Hospital, Department of Oncology
  More Information

No publications provided by Finnish Breast Cancer Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Riikka Huovinen, Finnish Brest Cancer Group
ClinicalTrials.gov Identifier: NCT00639210     History of Changes
Other Study ID Numbers: Protocol number FBCSG-01-2004
Study First Received: March 14, 2008
Last Updated: March 19, 2008
Health Authority: Finland: The Ethical Committee of Helsinki University (non-drug study)

Keywords provided by Finnish Breast Cancer Group:
breast cancer
exercise
osteoporosis
fracture
quality of life

Additional relevant MeSH terms:
Breast Neoplasms
Fractures, Bone
Osteoporosis
Recurrence
Osteoporotic Fractures
Neoplasms by Site
Neoplasms
Breast Diseases
 Skin Diseases
Wounds and Injuries
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013