BREAST CANCER AND EXERCISE

Brief Summary

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.”

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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
  • Study Primary Completion Date: September 2007

Detailed Clinical Trial 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.

Interventions Used in this Clinical Trial

  • 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.

Arms, Groups and Cohorts in this Clinical Trial

  • Other: 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.
  • No Intervention: B

Outcome Measures for this Clinical Trial

Primary 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
      Safety Issue?: Yes

Secondary Measures

  • Fitness and weight control, number of falls and fractures, breast cancer recurrence.
    • Time Frame: 1-10 years
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: 68 Years

Are Healthy Volunteers Accepted for this Clinical Trial: No

Clinical Trial Investigator Information

  • Lead Sponsor
    • Finnish Breast Cancer Group
  • Provider of Information About this Clinical Study
    • Riikka Huovinen, Finnish Brest Cancer Group
  • Overall Official(s)
    • Tiina Saarto, MD, PhD, Principal Investigator, Helsinki University Central Hospital, Department of Oncology

Source

Clinical Trials content is provided directly by the US National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of information about a specific clinical trial contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00639210