Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: Physical activity intervention
* Other: Control Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18 to 85 years First breast cancer HER2 + histologically confirmed, WHO grade Performance Index ≤1 Normal renal function (creatinine clearance ≥ 60 ml min-1) Normal heart function with LVEF ≥ 50% Normal liver function (AST and ALT normal) Physical activity certificate issued by a cardiologist or an oncologist, Active contraception or postmenopausal Exclusion Criteria: Patients aged under 18 and over 85 Patients having no breast cancer HER2+ Patients with metastases Heart failure (LVEF ≤50%) and respiratory (O2 saturation ≤ 92%), Autoimmune diseases (systemic lupus erythematosus, rheumatoid arthritis) Symptomatic osteoarthritis, Cardiovascular diseases (angina or uncontrolled high blood pressure) or heart-lung (chronic obstructive pulmonary disease) Patients suffering from malnutrition (Body Mass Index (BMI) <18 kg m-2) or weight loss of over 10% during the last 3 months, Patients with psychiatric or cognitive disorders deemed unsuitable for a sporting activity Pregnant or lactating Patients.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical activity intervention<br>- Arm A standard oncologic care coupled with physical activity intervention (3 times / week)  during 3 months | Other: Physical activity intervention<br>* Patients in arm A (interventional) will carry out a physical activity intervention during 3 months. Patients should perform an interval training program on cycle-ergometer during 3 sessions per week.<br>|
| Active Comparator: Control group<br>- Arm B (control group) standard oncologic care | Other: Control Group<br>* standard oncologic care<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Left Ventricular Ejection Fraction (LVEF) | evaluated with echocardiography | The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight and volume of left and right ventricular | evaluated with echocardiography | baseline (T0), 3 months (T3) and 6 months (T6) | 
| Body composition | evaluated byimpedance and with tape measure and pliers of Harpenden | baseline (T0), 3 months (T3) and 6 months (T6) | 
| Metabolic responses | evaluated with enzyme-linked immunosorbent assay (ELISA) | baseline (T0), 3 months (T3) and 6 months (T6) | 
| Maximal voluntary quadriceps | evaluated with chair quadriceps with strain gauge | baseline (T0), 3 months (T3) and 6 months (T6) | 
| score of Quality of life | evaluated with questionnaire | Baseline (T0), 3 months (T3) and 6 months (T6) | 
| score of Pain | evaluated with questionnaire | Baseline (T0), 3 months (T3) and 6 months (T6) | 
| Fatigue | evaluated with questionnaire | baseline (T0), 3 months (T3) and 6 months (T6) | 
| Level of physical activity | evaluated with questionnaire | baseline (T0), 3 months (T3) and 6 months (T6) | 
| Pulmonary function (at rest and during exercise) | evaluated with respiratory functional test and maximal exercise test | baseline (T0), 3 months (T3) and 6 months (T6) | 
| hormonal responses | evaluated with enzyme-linked immunosorbent assay (ELISA) | baseline (T0), 3 months (T3) and 6 months (T6) | 
| inflammatory responses | evaluated with enzyme-linked immunosorbent assay (ELISA) | baseline (T0), 3 months (T3) and 6 months (T6) |