BREAST CANCER AND EXERCISE

NCT ID: NCT00639210

Last Updated: 2019-02-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 573 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2007-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

supervised training

Intervention Type: OTHER

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.

B

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 68 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Finnish Breast Cancer Group

OTHER

Sponsor Role: lead

Responsible Party

Finnish Brest Cancer Group

Principal Investigators

Tiina Saarto, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Helsinki University Central Hospital, Department of Oncology

Locations

Helsinki University Central Hospital, Department of Oncology

Helsinki, , Finland

Countries

Finland

References

Blomqvist C, Vehmanen L, Kellokumpu-Lehtinen PL, Huovinen R, Ruohola J, Penttinen H, Sievanen H, Nikander R, Utriainen M, Saarto T. Long-term effects of aromatase inhibitor withdrawal on bone mineral density in early breast cancer patients: 10-year follow-up results of the BREX study. Breast Cancer Res Treat. 2024 Jul;206(1):57-65. doi: 10.1007/s10549-024-07252-7. Epub 2024 Apr 1.

Reference Type: DERIVED

PMID: 38561578 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 35136160 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 20878646 (View on PubMed)

Other Identifiers

Protocol number FBCSG-01-2004

Identifier Type: -

Identifier Source: org_study_id