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Breast Cancer FemaleNCT04337736

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

A study testing Physical exercise in people with Breast Cancer Female, run by ITAB - Institute for Advanced Biomedical Technologies.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages Up to 65 years, women only
Conditions the study is for
Breast Cancer Female
What is being tested?
Physical exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
57 participants
Where
No sites listed yet
Study dates
Apr 2016to Mar 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 65 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

About this study

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

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.

Read the 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.

Being tested
Physical exercise
Keywords
Physical exercise, Adherence to physical exercise, Global longitudinal strain, Ventricular-arterial coupling, Arterial stiffness, Epicardial fat thickness, Intima-media thickness, Endocrine therapy
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exerciseOther

Study groups in NCT04337736
Study groupRoleWhat they receive
Aerobic trainingActive comparator12-weeks, 3-days-a week, supervised aerobic (Nordic walking or Walking) physical exercise (PhE) protocol; duration of each PhE session: 70 minutes; rate of perceived exertion (RPE): 10-11 (1st-4th week); 12-13 (5th-8th week); 13-14 (9th-12th week).
Receives: Other: Physical exercise
Resistance trainingActive comparator12-weeks, 2.3-days-a week (total of 28 lessons), supervised resistance physical exercise (PhE) protocol; duration of each PhE session: 50 minutes.
Receives: Other: Physical exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 12-weeks (from the beginning of physical exercise training)

Secondary outcomes (5)

  1. Epicardial fat thickness reduction

    A reduction in epicardial fat thickness evaluated with echocardiographic method

    Measured: 12-weeks (from the beginning of physical exercise training)

  2. Intima-media thickness reduction

    A reduction in epicardial fat thickness evaluated with ultrasonographic method

    Measured: 12-weeks (from the beginning of physical exercise training)

  3. 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)

    Measured: 12-weeks (from the beginning of physical exercise training); a mean of 34 months from the enrollment

  4. 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)

    Measured: a mean of 34 months from the enrollment

  5. 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

    Measured: a mean of 34 months from the enrollment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2020
  2. Study startApr 2016
  3. Primary completionMay 2017
  4. Study completionMar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
57 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04337736
Sponsor's protocol ID
BCSPHE001
Status last verified
Apr 2020
First submitted
5 Apr 2020
Last updated
14 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 27567406

  • 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.

    PubMed 27998966

  • 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.

    PubMed 31626055

  • 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.

    PubMed 27110131

  • 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.

    PubMed 29530893

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise in people with Breast Cancer Female, run by ITAB - Institute for Advanced Biomedical Technologies.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improvement of cardio-vascular efficiency (time frame: 12-weeks (from the beginning of physical exercise training)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04337736, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.

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