Clinical trial NCT04337736: Effects of Physical Exercise on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors
Official title: The Impact of Different Physical Exercise Protocols on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: Physical exercise
Adherence to physical exercise
Global longitudinal strain
Ventricular-arterial coupling
Arterial stiffness
Epicardial fat thickness
Intima-media thickness
Endocrine therapy
Lead sponsor: ITAB - Institute for Advanced Biomedical Technologies
Sponsor class: OTHER
First posted: 2020-04-08
Enrollment: 57
Sex: FEMALE
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To examine the effects of different physical exercise protocols (aerobic training and resistance training) on cardio-vascular efficiency and quality of life in a population of breast cancer survivors (BCS), not treated with chemotherapy.

Detailed description: The present study enrolled a population of BCS women who underwent surgical treatment for breast cancer at the "Ospedale G. Bernabeo" of Ortona, Chieti, Italy. The participants were randomized to the following physical exercise protocols: aerobic training, walking or Nordic walking; resistance training.

All the participants have been examined utilizing transthoracic echocardiography, carotid ultrasound and photo-plethysmographic method for the analysis of arterial stiffness, before and after the physical exercise protocol (T0-T1). The two-dimensional speckle-tracking analysis was performed with an offline, dedicated software from the apical 4-chambers-view. Moreover, ventricular-arterial coupling, epicardial fat thickness and intima-media thickness were also analyzed.

Quality of life was assessed using SF-36 score at T0, T1 and at a mean follow-up of 34 months. Moreover, at follow-up, we evaluated spontaneous physical activity and cardiovascular quality of life using IPAQ and SAQ-7 scores.

Eligibility criteria: Inclusion Criteria:

* age \< 65 years;
* history of breast cancer surgery in the previous 12 months;
* no history of chemotherapy;
* no ongoing radiotherapy;
* eventual hormonal therapy;
* cardiovascular and orthopedic eligibility.

Exclusion Criteria:

* adjuvant chemotherapy;
* any history of cardiovascular disease;
* abnormal exercise stress test at the screening;
* any systemic inflammatory disease or any orthopedic condition potentially limiting the physical training.

Primary outcomes:
measure: Improvement of cardio-vascular efficiency
timeFrame: 12-weeks (from the beginning of physical exercise training)
Secondary outcomes:
measure: Epicardial fat thickness reduction
timeFrame: 12-weeks (from the beginning of physical exercise training)
measure: Intima-media thickness reduction
timeFrame: 12-weeks (from the beginning of physical exercise training)
measure: Improvement of quality of life
timeFrame: 12-weeks (from the beginning of physical exercise training); a mean of 34 months from the enrollment
measure: Improvement of spontaneous physical activity
timeFrame: a mean of 34 months from the enrollment
measure: Improvement of cardiovascular quality of life
timeFrame: a mean of 34 months from the enrollment
Other outcomes:
Locations:
Study officials:
affiliation: ITAB - Institute for Advanced Biomedical Technologies
name: Francesco Bianco, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: ITAB - Institute for Advanced Biomedical Technologies
name: Valentina Bucciarelli, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zamorano JL, Lancellotti P, Rodriguez Munoz D, Aboyans V, Asteggiano R, Galderisi M, Habib G, Lenihan DJ, Lip GYH, Lyon AR, Lopez Fernandez T, Mohty D, Piepoli MF, Tamargo J, Torbicki A, Suter TM; ESC Scientific Document Group. 2016 ESC Position Paper on cancer treatments and cardiovascular toxicity developed under the auspices of the ESC Committee for Practice Guidelines: The Task Force for cancer treatments and cardiovascular toxicity of the European Society of Cardiology (ESC). Eur Heart J. 2016 Sep 21;37(36):2768-2801. doi: 10.1093/eurheartj/ehw211. Epub 2016 Aug 26. No abstract available.
citation: Khosrow-Khavar F, Filion KB, Al-Qurashi S, Torabi N, Bouganim N, Suissa S, Azoulay L. Cardiotoxicity of aromatase inhibitors and tamoxifen in postmenopausal women with breast cancer: a systematic review and meta-analysis of randomized controlled trials. Ann Oncol. 2017 Mar 1;28(3):487-496. doi: 10.1093/annonc/mdw673.
citation: Campbell KL, Winters-Stone KM, Wiskemann J, May AM, Schwartz AL, Courneya KS, Zucker DS, Matthews CE, Ligibel JA, Gerber LH, Morris GS, Patel AV, Hue TF, Perna FM, Schmitz KH. Exercise Guidelines for Cancer Survivors: Consensus Statement from International Multidisciplinary Roundtable. Med Sci Sports Exerc. 2019 Nov;51(11):2375-2390. doi: 10.1249/MSS.0000000000002116.
citation: Zhu G, Zhang X, Wang Y, Xiong H, Zhao Y, Sun F. Effects of exercise intervention in breast cancer survivors: a meta-analysis of 33 randomized controlled trails. Onco Targets Ther. 2016 Apr 13;9:2153-68. doi: 10.2147/OTT.S97864. eCollection 2016.
citation: Scott JM, Nilsen TS, Gupta D, Jones LW. Exercise Therapy and Cardiovascular Toxicity in Cancer. Circulation. 2018 Mar 13;137(11):1176-1191. doi: 10.1161/CIRCULATIONAHA.117.024671.