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BREAST CANCER AND EXERCISE (BREX)

Primary Purpose

Prevent Osteoporosis and Osteoporotic Fractures, Improve Quality of Life, Improve Weight Control, and Muscular and Cardiovascular Fitness

Status

Completed

Phase

Phase 3

Locations

Finland

Study Type

Interventional

Intervention

supervised training

About this trial

This is an interventional prevention trial for Prevent Osteoporosis and Osteoporotic Fractures focused on measuring breast cancer, exercise, osteoporosis, fracture, quality of life

Eligibility Criteria

35 Years - 68 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Helsinki University Central Hospital, Department of Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Arm Description

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.

Outcomes

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.

Secondary Outcome Measures

Fitness and weight control, number of falls and fractures, breast cancer recurrence.

Full Information

NCT ID

NCT00639210

First Posted

March 14, 2008

Last Updated

February 24, 2019

Sponsor

Finnish Breast Cancer Group

1. Study Identification

Unique Protocol Identification Number

NCT00639210

Brief Title

BREAST CANCER AND EXERCISE

Acronym

BREX

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.

Study Type

Interventional

2. Study Status

Record Verification Date

February 2019

Overall Recruitment Status

Completed

Study Start Date

September 2005 (undefined)

Primary Completion Date

September 2007 (Actual)

Study Completion Date

September 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Finnish Breast Cancer Group

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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, Reduce All-cause Mortality in Patients With Primary Breast Cancer

Keywords

breast cancer, exercise, osteoporosis, fracture, quality of life

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

573 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Other

Arm Description

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.

Arm Title

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

supervised training

Intervention Description

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.

Primary Outcome Measure Information:

Title

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

Secondary Outcome Measure Information:

Title

Fitness and weight control, number of falls and fractures, breast cancer recurrence.

Time Frame

1-10 years

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

35 Years

Maximum Age & Unit of Time

68 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tiina Saarto, MD, PhD

Organizational Affiliation

Helsinki University Central Hospital, Department of Oncology

Official's Role

Principal Investigator

Facility Information:

Facility Name

Helsinki University Central Hospital, Department of Oncology

City

Helsinki

ZIP/Postal Code

00029

Country

Finland

12. IPD Sharing Statement

Citations:

PubMed Identifier

35136160

Citation

Poikonen-Saksela P, Kolokotroni E, Vehmanen L, Mattson J, Stamatakos G, Huovinen R, Kellokumpu-Lehtinen PL, Blomqvist C, Saarto T. A graphical LASSO analysis of global quality of life, sub scales of the EORTC QLQ-C30 instrument and depression in early breast cancer. Sci Rep. 2022 Feb 8;12(1):2112. doi: 10.1038/s41598-022-06138-2.

Results Reference

derived

PubMed Identifier

20878646

Citation

Penttinen HM, Saarto T, Kellokumpu-Lehtinen P, Blomqvist C, Huovinen R, Kautiainen H, Jarvenpaa S, Nikander R, Idman I, Luoto R, Sievanen H, Utriainen M, Vehmanen L, Jaaskelainen 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.

Results Reference

derived

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