Attenuating Cancer Treatment-related Toxicity in Oncology Patients With a Tailored Physical Exercise Program: Study Protocol of the ATOPE Trial in Women Recently Diagnosed With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Left ventricular ejection fraction
研究概览
简要总结
The aim of this study is to determine if therapeutic exercise before anticancer treatment will mitigate the onset or extent of cardiotoxicity comparing to therapeutic exercise performed during anticancer treatment.
详细描述
The positive relationship between physical exercise and cancer is widely justified in the literature, but an emerging research line warns of its capacity to improve the effectiveness and reduce the toxicity of cancer treatment (responsible for the appearance of side effects and comorbidities), that overload the health care system. To date, there is a lack of knowledge in different subjects: the possibility of implementing individualized exercise programs in clinical environment to mitigate the side effects of cancer treatment; the best moment in natural history of the disease to perform therapeutic exercise; and a tailored dose of exercise that maximizes its benefits.
In this context, the present study will evaluate the effects of a therapeutic exercise program conducted previously at the beginning of the cancer treatment, in the treatments' toxicity against the same program conducted during cancer treatments in women with breast cancer, and its positive effects on both clinical and biological variables and their possible impact on disease-free survival.
This study will be conducted in 3 phases with 110 participants in total: phase 1: a pilot study be carried out to check the feasibility of the proposed physical exercise program; phase 2: to test the effectiveness of the program ATOPE performed prior to surgical medical treatment against the same made during treatment, with a randomized controlled clinical trial; and phase 3: in which it will be integrated into the health service and a larger project will be requested at the international level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Breast cancer diagnosis I-III stage
- •On the waiting list to anticancer medical treatment (at least surgery, chemotherapy and radiotherapy.
- •If they meet other criteria which predisposes to higher toxicity.
- •Have signed informed consent.
- •Have medical clearance for participation.
排除标准
- •Patient underwent previous cancer treatments.
- •Patients were previously diagnosed with cancer.
- •Pregnant patients.
- •Patients performing other type of therapeutic exercise at diagnosis time with an intake >or = to 150 moderate-intensity or 75 min of vigorous-intensity a day.
- •Therapeutic exercise practice not recommended because psychiatric or cognitive disorders or cute or chronic condition that prevents exercise (advanced lung disease, oxygen requirement, stenosis >70%, metastasis etc.).
结局指标
主要结局
Left ventricular ejection fraction
时间窗: Participants will be followed over 12 months
To assess cardiac toxicity by echocardiography
次要结局
- Flexibility(Participants will be followed over 12 months)
- Waist and hip circumferences(Participants will be followed over 12 months)
- Body composition(Participants will be followed over 12 months)
- Inmune function(Participants will be followed over 12 months)
- Muscle loss(Participants will be followed over 12 months)
- Number of hospitalizations.(Participants will be followed over 12 months)
- Quality of life with the Quality of life Questionnaire (QLQ- BR23) a specific module.(Participants will be followed over 12 months but will not be assessed in baseline)
- Chemotherapy doses modifications(Participants will be followed over 12 months)
- Missing bouts due to adverse effects of chemotherapy(Participants will be followed over 12 months)
- Time to treatment failure(Participants will be followed over 12 months)
- Program adverse effects reported by the participants.(Participants will be followed over 12 months)
- Cardiovascular events(Participants will be followed over 12 months)
- Resting heart rate(Participants will be followed over 12 months)
- Heart Rate variability(Participants will be followed over 12 months)
- Quality of life with the Quality of Life Questionnaire (QLQ)-C30(Participants will be followed over 12 months)
- Early session termination.(Participants will be followed over 12 months)
- Oxidative stress(Participants will be followed over 12 months)
- Abdominal strength(Participants will be followed over 12 months)
- Chemotherapy regimen(Participants will be followed over 12 months)
- Therapeutic exercise bout modification(Participants will be followed over 12 months)
- Functional capacity(Participants will be followed over 12 months)
- Handgrip strength(Participants will be followed over 12 months)
- Shoulder strength(Participants will be followed over 12 months)
- Lower limb strength(Participants will be followed over 12 months)
- inflammation(Participants will be followed over 12 months)
研究者
Irene Cantarero Villanueva
Principal Investigator
Universidad de Granada