Phase I Dose-escalation Study of Adapted Physical Activity in Children and Adolescent Suffering From Advanced Malignancies.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Perceived tolerance
研究概览
简要总结
Adapted physical activity (APA) in the context of cancer is a field of growing interest and has been explored in numerous publications. In adults, the effects of APA on survival, symptoms and quality of life are established and its physiological consequences on immunity, angiogenesis and hormone secretion are under investigation.
In children and adolescents, evidence is scarce: pilot studies show clinical benefit of physical activity practiced in a wide variety of situations and protocols with low level of scientific evidence. It is therefore not possible to recommend this practice in pediatrics despite the large number of initiatives and the conviction of many clinicians that there is a benefit for patients. In particular, there are few trials in children with advanced cancer pathologies or in palliative care. However, these patients have a high prevalence of severe symptoms (pain, digestive disorders, asthenia, and anxiety) for which physical activity may represent a therapeutic option.
The purpose of our study is to describe a protocol of adapted physical activity and to evaluate its feasibility and toxicity according to a well-known and validated methodology in oncology used in drug development.
Methodology is based on a simple and reproducible intervention combining brisk walking on treadmill and exercises of muscular strengthening with varying durations and intensities depending on physical capabilities of patients.
The primary objective is to define the volume of physical activity that can be proposed to a patient starting APA based on the assessment of his physical condition evaluated by a 6-minutes walking distance test.
Inclusion criteria are broad to allow study population to represent the diversity of patients in pediatric palliative oncology. Stratification of patients in three groups based on a 6-minutes walking distance test aims to adapt intervention to physical capability of patients and improve tolerance.
Dose escalation will be set with a "3 + 3" regimen used in drug early phases trials.
Primary outcome measure is perceived tolerance evaluated by the patient with a subjective scoring on CREST scale. Any score greater than 8/10 defines intolerance.
详细描述
Adapted physical activity (APA) in the context of cancer is a field of growing interest and has been explored in numerous publications. In adults, the effects of APA on survival, symptoms and quality of life are established and its physiological consequences on immunity, angiogenesis and hormone secretion are under investigation.
In children and adolescents, evidence is scarce: pilot studies show clinical benefit of physical activity practiced in a wide variety of situations and protocols with low level of scientific evidence. It is therefore not possible to recommend this practice in pediatrics despite the large number of initiatives and the conviction of many clinicians that there is a benefit for patients. In particular, there are few trials in children with advanced cancer pathologies or in palliative care. However, these patients have a high prevalence of severe symptoms (pain, digestive disorders, asthenia, and anxiety) for which physical activity may represent a therapeutic option.
The purpose of our study is to describe a protocol of adapted physical activity and to evaluate its feasibility and toxicity according to a well-known and validated methodology in oncology used in drug development.
Methodology is based on a simple and reproducible intervention combining brisk walking on treadmill and exercises of muscular strengthening with varying durations and intensities depending on physical capabilities of patients.
The primary objective is to define the volume of physical activity that can be proposed to a patient starting APA based on the assessment of his physical condition evaluated by a 6-minutes walking distance test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged from 5 to 17 years old.
- •Cancer with no curative therapeutic options.
- •Stable disease (with or without treatment).
- •Ability to complete 100 meters walking without help and muscular strengthening exercises.
- •Written informed consent, including agreement of parents or legal guardian for minors.
排除标准
- •Participation to another Phase I trial
- •Dyspnoea exertional
- •Cardio-vascular pathology
- •Life expectancy of less than 3 months
- •Progressive disease
- •Expected inability to comply to medical follow up
研究组 & 干预措施
EXPERIMENTAL GROUP
patients in advanced phase of pediatric cancer Physical activity training will be performed in drug development
干预措施: Physical activity training (Other)
结局指标
主要结局
Perceived tolerance
时间窗: 6 weeks
Evaluated by the patient with a subjective scoring on scale (from 0 to 10). Any score greater than 8/10 define intolerance. Any score under 8/10 definite "acceptable tolerance"
次要结局
未报告次要终点