Breast Cancer Clinical Trial
Official title:
Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant
Purpose of the study is to examine the effects of 3 months of physical activity intervention on myocardial function (Left ventricular ejection fraction) in patients with HER2+ breast cancer
Primary objective: To evaluate in patients with HER2 + breast cancer, treated only by
trastuzumab, the impact of three months individualized physical activity intervention (55
minutes, 3 times per week) on left ventricular ejection fraction (LVEF).
Secondary objectives: To evaluate the impact of physical activity intervention on body
composition, muscle function, metabolic, hormonal and inflammatory responses, pain, fatigue
and quality of life.
This study examines patients aged 18 to 85 years, diagnosed with early breast cancer with
HER2 overexpression confirmed histologically and eligible to receive treatment with
trastuzumab (adjuvant).
This study includes 3 assessments phases: baseline (T0), 3 months (T3) and 6 months (T6) for
both arms.
The programme is organised as follows: Arm A "standard oncologic care coupled with physical
activity intervention (3 times / week) " for 3 months ; Arm B (control group) "standard
oncologic care".
Between T3 and T6, volontary physical activity level will follow by actimetry.
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