Arterial Stiffness in Individuals With Breast Cancer

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40-69
SponsorHacettepe University

About this trial

The aim of this study was to evaluate vascular toxicity induced by anthracyclines and other anticancer drugs and to measure arterial stiffness in women with breast cancer and, in addition, to evaluate the acute and chronic arterial stiffness responses of upper extremity aerobic exercise training.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

To be between the ages of 40-69,

Baseline left ventricular ejection fraction (LVEF) >50%,

Absence of coronary artery disease and haemodynamically significant valvular heart disease,

Absence of carotid atherosclerotic plaques,

Disqualifiers

Presence of active infection,

Presence of bilateral breast cancer,

History of surgical, neurological or orthopaedic problems that may affect upper extremity functionality other than breast cancer surgery,

Having a neurological disease or other clinical diagnosis that may affect cognitive status,

Trial design

Design model

Single group

Treatments tested in this trial

  • Upper Extremity Aerobic Exercise Training Program

    Other intervention

    12 weeks of supervised upper limb aerobic exercise training, 3 sessions per week, 25 minutes per session.

Treatment groups

18 Participants
are divided into 1 treatment group
Group A: Upper Extremity Aerobic ExerciseOther 1 intervention

Trial outcomes

Primary outcomes

1

Arterial Stiffness

Arterial stiffness will be assessed noninvasively using the pulse wave velocity (PWV) technique with the Mobil-O-GRAPH (TG) (I.E.M., Stolberg, Germany), an oscillometer-based device. Pulse wave velocity, augmentation pressure, reflection magnitude, agumentation index parameters will be recorded.

Time frame
one years

Secondary outcomes

1

Comorbidity Assessment

The Charlson Comorbidity Index According to this index developed by the Institute of Medicine, comorbid diseases are assessed according to their severity. is scored. Comorbidities are scored from mild disease state to severe disease state. are given a score of 1, 2, 3, 4, respectively, and the score obtained by summing the scores of comorbid diseases The severity of comorbidity is also calculated according to the weighted score. One point for every ten years over the age of forty (50-59: 1 point, 60-69: 2 points, etc.)

Time frame
one year
2

Maximal Arm Exercise Capacity

VO2peak requirement during arm ergometry will be estimated using MET levels calculated at each power output based on gender at various body weights and will be displayed in ml/kg/min (1 MET = 3.5 ml/kg/min)

Time frame
one year
3

Cardiovascular Disease Risk Scoring

To be evaluated with SCORE2. The risk calculated according to the SCORE system is accepted as low risk if \<1%, medium risk if 1-4%, high risk if 5-9%, and very high risk if 10% and above (16). According to the SCORE2 system, \<2.5% is considered low-moderate risk, 2.5%-7.5% is considered high risk, and 7.5% and above is considered very high risk in patients aged \<50 years. In those over 50 years of age, \<5% is considered low-moderate risk, 5-10% is considered high risk, and 10% and above is considered very high risk.

Time frame
one year

Other outcomes

Sponsors and contacts

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