BREAST CANCER AND EXERCISE

NCT00639210 | Completed Phase 3 DMC

• 1 other identifier: Protocol number FBCSG-01-2004
• Study Type: interventional
• Target: 573
• Locations: 1 country
• Sites: 1

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.

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  1-10 years

Secondary Outcomes (1)

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

  1-10 years

Study Arms (2)

A

OTHER

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

B

NO INTERVENTION

Interventions

supervised training 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.

A

Eligibility Criteria

• Age: 35 Years - 68 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• 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

Sponsors & Collaborators

• Finnish Breast Cancer Group: lead

Study Sites (1)

Helsinki University Central Hospital, Department of Oncology

Helsinki, 00029, Finland

Location

Related Publications (3)

• 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.

  PMID: 38561578 DERIVED

• 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.

  PMID: 35136160 DERIVED

• 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.

  PMID: 20878646 DERIVED

MeSH Terms

Conditions

Osteoporotic Fractures; Breast Neoplasms; Motor Activity; Osteoporosis; Fractures, Bone

Condition Hierarchy (Ancestors)

Wounds and Injuries; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Tiina Saarto, MD, PhD

  Helsinki University Central Hospital, Department of Oncology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 14, 2008
• First Posted: March 20, 2008
• Study Start: September 1, 2005
• Primary Completion: September 1, 2007
• Study Completion: September 1, 2007
• Last Updated: February 26, 2019

Record last verified: 2019-02

Locations

FI (1)