BREAST CANCER AND EXERCISE (BREX)

February 24, 2019 updated by: Finnish Breast Cancer Group

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 Overview

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 Type

Interventional

Enrollment (Actual)

573

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Helsinki, Finland, 00029
        • Helsinki University Central Hospital, Department of Oncology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 68 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: B
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
1-10 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Fitness and weight control, number of falls and fractures, breast cancer recurrence.
Time Frame: 1-10 years
1-10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Tiina Saarto, MD, PhD, Helsinki University Central Hospital, Department of Oncology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

March 14, 2008

First Submitted That Met QC Criteria

March 19, 2008

First Posted (Estimate)

March 20, 2008

Study Record Updates

Last Update Posted (Actual)

February 26, 2019

Last Update Submitted That Met QC Criteria

February 24, 2019

Last Verified

February 1, 2019

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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