Effects of Physical Exercise on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors

Breast Cancer Female Clinical Trial

Official title:

The Impact of Different Physical Exercise Protocols on Cardio-vascular Efficiency and Quality of Life in Breast Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04337736
• Other study ID #: BCSPHE001
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: March 2020

Study information

• Verified date: April 2020
• Source: ITAB - Institute for Advanced Biomedical Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: March 2020
• Est. primary completion date: May 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms

Intervention

Other:
• Physical exercise

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ITAB - Institute for Advanced Biomedical Technologies

References & Publications (5)

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. — View 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. Review. — View 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. Review. — View Citation

Zamorano JL, Lancellotti P, Rodriguez Muñoz 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. Erratum in: Eur Heart J. 2016 Dec 24;:. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of cardio-vascular efficiency	A composite of the improvement in the following parameters, from pre-treatment values: global longitudinal strain analysis, as assessed by speckle-traking echocardiography; ventricular-arterial coupling, as assessed by echocardiographic single beat method; arterial stiffness (pulse wave velocity, augmentation index), as assessed by photoplethysmographic method	12-weeks (from the beginning of physical exercise training)
Secondary	Epicardial fat thickness reduction	A reduction in epicardial fat thickness evaluated with echocardiographic method	12-weeks (from the beginning of physical exercise training)
Secondary	Intima-media thickness reduction	A reduction in epicardial fat thickness evaluated with ultrasonographic method	12-weeks (from the beginning of physical exercise training)
Secondary	Improvement of quality of life	An improvement of quality of life, from pre-treatment values, evaluated with the 36-Item Short Form Health Survey (minimum value: 0, associated with the worst quality of life; maximum value: 100, associated with the best quality of life)	12-weeks (from the beginning of physical exercise training); a mean of 34 months from the enrollment
Secondary	Improvement of spontaneous physical activity	An improvement of spontaneous physical activity evaluated with International Physical Activity Questionnaire score (0-700 MET: low level of physical activity; 700-2519 MET: intermediate level of physical activity; > 2520 MET: high level of physical activity)	a mean of 34 months from the enrollment
Secondary	Improvement of cardiovascular quality of life	An improvement of quality of life evaluated with the Seattle Angina Questionnaire-7 score (minimum value: 0, associated with more symptoms and with the worst quality of life; maximum value: 100, associated with fewer symptoms and with the best quality of life) where higher scores indicate fewer symptoms and higher health-related quality of life	a mean of 34 months from the enrollment