Breast Cancer
Conditions
Brief summary
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
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.
Interventions
OTHERPhysical activity intervention
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.
OTHERControl Group
standard oncologic care
Sponsors
Ligue contre le cancer, France
Centre Hospitalier Universitaire de Besancon
University of Franche-Comté
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Left Ventricular Ejection Fraction (LVEF) | The Left Ventricular Ejection Fraction (LVEF) will be evaluated baseline (T0), and 6 months (T6), to see if there is a significant change | evaluated with echocardiography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body composition | baseline (T0), 3 months (T3) and 6 months (T6) | evaluated byimpedance and with tape measure and pliers of Harpenden |
| Metabolic responses | baseline (T0), 3 months (T3) and 6 months (T6) | evaluated with enzyme-linked immunosorbent assay (ELISA) |
| Maximal voluntary quadriceps | baseline (T0), 3 months (T3) and 6 months (T6) | evaluated with chair quadriceps with strain gauge |
| score of Quality of life | Baseline (T0), 3 months (T3) and 6 months (T6) | evaluated with questionnaire |
| score of Pain | Baseline (T0), 3 months (T3) and 6 months (T6) | evaluated with questionnaire |
| Weight and volume of left and right ventricular | baseline (T0), 3 months (T3) and 6 months (T6) | evaluated with echocardiography |
| Level of physical activity | baseline (T0), 3 months (T3) and 6 months (T6) | evaluated with questionnaire |
| Pulmonary function (at rest and during exercise) | baseline (T0), 3 months (T3) and 6 months (T6) | evaluated with respiratory functional test and maximal exercise test |
| hormonal responses | baseline (T0), 3 months (T3) and 6 months (T6) | evaluated with enzyme-linked immunosorbent assay (ELISA) |
| inflammatory responses | baseline (T0), 3 months (T3) and 6 months (T6) | evaluated with enzyme-linked immunosorbent assay (ELISA) |
| Fatigue | baseline (T0), 3 months (T3) and 6 months (T6) | evaluated with questionnaire |
Countries
France
Outcome results
None listed