Clinical trial NCT00639210: BREAST CANCER AND EXERCISE
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
Overall status: COMPLETED
Phase: PHASE3
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
Lead sponsor: Finnish Breast Cancer Group
Sponsor class: OTHER
First posted: 2008-03-20
Enrollment: 573
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 68
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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.
timeFrame: 1-10 years
Secondary outcomes:
measure: Fitness and weight control, number of falls and fractures, breast cancer recurrence.
timeFrame: 1-10 years
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Central Hospital, Department of Oncology
Study officials:
affiliation: Helsinki University Central Hospital, Department of Oncology
name: Tiina Saarto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.