Impact of Physical Activity Intervention on Myocardial Function in Patients With HER2 + Breast Cancer, During Treatment With Trastuzumab in Adjuvant
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Left Ventricular Ejection Fraction (LVEF)
研究概览
简要总结
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
详细描述
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".
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
Physical activity intervention
- Arm A "standard oncologic care coupled with physical activity intervention (3 times / week) " during 3 months
干预措施: Physical activity intervention (Other)
Control group
- Arm B (control group) "standard oncologic care"
干预措施: Control Group (Other)
结局指标
主要结局
Left Ventricular Ejection Fraction (LVEF)
时间窗: 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
次要结局
- Weight and volume of left and right ventricular(baseline (T0), 3 months (T3) and 6 months (T6))
- Body composition(baseline (T0), 3 months (T3) and 6 months (T6))
- score of Quality of life(Baseline (T0), 3 months (T3) and 6 months (T6))
- score of Pain(Baseline (T0), 3 months (T3) and 6 months (T6))
- Metabolic responses(baseline (T0), 3 months (T3) and 6 months (T6))
- Fatigue(baseline (T0), 3 months (T3) and 6 months (T6))
- Level of physical activity(baseline (T0), 3 months (T3) and 6 months (T6))
- Pulmonary function (at rest and during exercise)(baseline (T0), 3 months (T3) and 6 months (T6))
- hormonal responses(baseline (T0), 3 months (T3) and 6 months (T6))
- Maximal voluntary quadriceps(baseline (T0), 3 months (T3) and 6 months (T6))
- inflammatory responses(baseline (T0), 3 months (T3) and 6 months (T6))
研究者
Fabienne Mougin-Guillaume
Ph.D
University of Franche-Comté