Research Centre in Physical Activity, Health and Leisure, Faculty of Sport, University of Porto, Portugal.
Contemp Clin Trials. 2013 Sep;36(1):106-15. doi: 10.1016/j.cct.2013.05.012. Epub 2013 Jun 5.
This randomized controlled trial on Physical Activity in Pediatric Cancer (PAPEC) was designed to assess the impact of an exercise program on pediatric cancer patients undergoing chemotherapy for solid tumors.
60 pediatric patients of both sexes, aged 4 to 18 years and undergoing treatment for extracranial primary solid tumors will be recruited for this trial. Each participant will be randomly assigned (with blocking on sex) to either an intervention or control (normal care) group. The intervention group will participate in combined inpatient physical training (aerobic + strength) for the duration of neoadjuvant chemotherapy. The intervention will include 3 weekly 60-70 min exercise sessions in the child's room or in a pediatric gym at the hospital, depending on the child's health state. In both groups, determination of several primary (cardio-respiratory fitness, muscle strength, functional capacity, physical activity levels, body weight and quality of life) and secondary outcomes [immune function and inflammatory profile (blood levels of 47 cytokines)] will be made at the following time points: (i) before the exercise intervention (immediately after diagnosis and before treatment onset); (ii) after the exercise intervention (upon termination of neoadjuvant chemotherapy); and (iii) after a detraining period (2 months after the intervention).
The PAPEC trial will provide relevant new information on biological mechanisms and inform on the potential clinical use of exercise during pediatric cancer treatment as a simple way to prevent future long-term treatment effects and improve the general health state of pediatric cancer patients.
本项关于儿科癌症患者体力活动（PAPEC）的随机对照试验旨在评估一项锻炼计划对接受实体瘤化疗的儿科癌症患者的影响。
本试验将招募 60 名年龄在 4 至 18 岁之间、接受颅外原发性实体瘤治疗的男女患儿。每位参与者将被随机分配（按性别分组）至干预组或对照组（常规护理）。干预组将在新辅助化疗期间接受联合住院身体训练（有氧+力量）。干预措施将包括在患儿房间或医院儿科健身房每周进行 3 次 60-70 分钟的锻炼课程，具体取决于患儿的健康状况。在两组中，将在以下时间点测定几个主要（心肺适能、肌肉力量、功能能力、身体活动水平、体重和生活质量）和次要结局[免疫功能和炎症特征（47 种细胞因子的血液水平）]：（i）在运动干预前（诊断后和治疗开始前）；（ii）在运动干预后（新辅助化疗结束时）；和（iii）在停训期后（干预后 2 个月）。
PAPEC 试验将提供有关生物学机制的相关新信息，并为儿科癌症治疗期间运动的潜在临床应用提供信息，这是一种预防未来长期治疗效果和改善儿科癌症患者整体健康状况的简单方法。
