Dataset Information

Exercise as a diagnostic and therapeutic tool for preventing cardiovascular morbidity in breast cancer patients- the BReast cancer EXercise InTervention (BREXIT) trial protocol.

ABSTRACT:

Background

Anthracycline chemotherapy (AC) is an efficacious (neo) adjuvant treatment for early-stage breast cancer (BCa), but is associated with an increased risk of cardiac dysfunction and functional disability. Observations suggest that regular exercise may be a useful therapy for the prevention of cardiovascular morbidity but it is yet to be interrogated in a large randomised trial. The primary aims of this study are to: 1) determine if 12-months of ET commenced at the onset of AC can reduce the proportion of BCa patients with functional disability (peak VO₂, MethodsOne hundred women with early-stage BCa (40-75?years) scheduled for AC will be randomized to 12-months of structured exercise training (n?=?50) or a usual care control group (n?=?50). Participants will be assessed at baseline, 4-weeks following completion of AC (4-months) and at 12-months for all measures.

Discussion

Women diagnosed with early-stage BCa have increased cardiac mortality. More sensitive strategies for diagnosing and preventing AC-induced cardiovascular impairment are critical for reducing cardiovascular morbidity and improving long-term health outcomes in BCa survivors.

Trial registration

Australia & New Zealand Clinical Trials Registry (ANZCTR), ID: 12617001408370 . Registered on 5th of October 2017.

SUBMITTER: Foulkes SJ

PROVIDER: S-EPMC7362469 | biostudies-literature | 2020 Jul

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Exercise as a diagnostic and therapeutic tool for preventing cardiovascular morbidity in breast cancer patients- the BReast cancer EXercise InTervention (BREXIT) trial protocol.

Foulkes Stephen J SJ Howden Erin J EJ Antill Yoland Y Loi Sherene S Salim Agus A Haykowsky Mark J MJ Daly Robin M RM Fraser Steve F SF La Gerche Andre A

BMC cancer 20200714 1

<h4>Background</h4>Anthracycline chemotherapy (AC) is an efficacious (neo) adjuvant treatment for early-stage breast cancer (BCa), but is associated with an increased risk of cardiac dysfunction and functional disability. Observations suggest that regular exercise may be a useful therapy for the prevention of cardiovascular morbidity but it is yet to be interrogated in a large randomised trial. The primary aims of this study are to: 1) determine if 12-months of ET commenced at the onset of AC ca ...[more]

PMID: 32664946

Similar Datasets

Project description:ImportanceThe Framingham Risk Score (FRS) is a valid method for predicting the 10-year risk of developing cardiovascular disease. Higher FRS is reported in patients with early-stage breast cancer who are overweight than in healthy, age-matched women, but whether exercise reduces FRS in this patient population is unclear.ObjectiveTo examine the effects of a 16-week aerobic and resistance exercise intervention on the FRS in women with early-stage breast cancer and with overweight condition or obesity.Design, setting, and participantsThis single-center, prospective randomized clinical trial included 100 women with stage I to III breast cancer who were sedentary, with overweight condition or obesity (body mass index of ≥25.0 or body fat of ≥30%), and completed cancer treatment within 6 months prior to enrollment. Participants were randomized to either the usual care or exercise group. Differences in mean changes for outcomes were evaluated using mixed-model repeated-measures analyses. Data were collected from August 1, 2012, through July 1, 2017. Data analysis, which followed the intention-to-treat approach, was performed from May 24 to October 2, 2018.InterventionsThe exercise group underwent supervised aerobic and resistance exercise sessions thrice weekly for 16 weeks.Main outcomes and measuresThe FRS was calculated for each participant using preset points for each of the 6 FRS categories: age, systolic blood pressure, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, diabetes presence, and smoking status.ResultsIn total, 100 women were randomized to either the exercise group (n = 50) or usual care group (n = 50). Of these women, 55 (55%) were of Hispanic white race/ethnicity and the mean (SD) age was 53.5 (10.4) years. The mean (SD) total FRS scores postintervention were 2.0 (1.5) in the exercise group and 13.0 (3.0) in the usual care group. The postintervention FRS was significantly reduced in the exercise group compared with the usual care group (mean, -9.5; 95% CI, -13.0 to -6.0), which corresponds to an 11% (95% CI, -15.0 to -5.0) decrease on the FRS-predicted 10-year risk of developing cardiovascular disease.Conclusions and relevanceA 16-week supervised aerobic and resistance exercise intervention appeared to reduce the FRS-predicted 10-year risk of cardiovascular disease in women with early-stage breast cancer with overweight condition or obesity.Clinical trial registrationClinicalTrials.gov identifier: NCT01140282.

Dataset Information

Exercise as a diagnostic and therapeutic tool for preventing cardiovascular morbidity in breast cancer patients- the BReast cancer EXercise InTervention (BREXIT) trial protocol.

Background

Discussion

Trial registration

Publications

Exercise as a diagnostic and therapeutic tool for preventing cardiovascular morbidity in breast cancer patients- the BReast cancer EXercise InTervention (BREXIT) trial protocol.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets