Thomas Justine, Filleron Thomas, Auriol Françoise, Laurens Claire, Pasquet Marlène
Department of Pediatric Hematology and Immunology, Toulouse University Hospital Center, 339 Avenue de Grande Bretagne, Toulouse, 31059, France.
University of Toulouse, Institute of Metabolic and Cardiovascular Diseases, UMR 1297 Inserm, Team Metadiab, Toulouse, France.
BMC Cancer. 2025 May 9;25(1):850. doi: 10.1186/s12885-025-14235-4.
Insulin sensitivity is a key factor of the development of metabolic diseases, highly prevalent in adult survivors of childhood cancers. The aim of the Adapted Physical Activity for children treated for Cancer and Insulin-Sensitivity (APACIS) study is to investigate the effects of two exercise programs started as early as diagnosis on metabolic profile and physical health.
APACIS is a trial that includes children at diagnosis of all pediatric cancers which are randomly allocated to the Soft group - for low intensity physical activity - or to the Strong group - for mixed, high intensity exercise. Both programs are done at least twice weekly for 30 to 60 min over 6 months, adapted to the health status of the children, with a follow-up of 18 months. The primary objective is the change in insulin sensitivity measured by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) at 0, 3, 6, 12 and 24 months between the two groups. The secondary objectives include changes in cholesterol, triglycerides and cortisol blood levels, state of undernourishment, cardiorespiratory fitness (based on peak rate of oxygen uptake of the 6 Minute Walk Test), flexibility (sit and reach flexibility test), fat mass distribution (Waist-to-Hip Ratio) and level of physical activity assessed by questionnaire at 0, 3, 6, 12 and 24 months. On-therapy metabolic adaptation in the different patient groups will also be evaluated by an integrated pipeline combining the detection of 150 metabolites, with metabolic pathway enrichment and network mapping. This approach will be complemented by an analysis of intestinal and oral microbiota, to identify the species impacted by treatments and the influence of exercise on these toxicities.
The APACIS study investigates the metabolic, motor, and nutritional effects in children with cancers performing low versus high intensity exercise with an innovative approach consisting of early practice since diagnosis. It will contribute to better personalize physical activity prescription during treatment of pediatric cancers.
The study has been registered on ClinicalTrials.gov (NCT05383092) the 7 of November, 2022.
胰岛素敏感性是代谢性疾病发展的关键因素，在儿童癌症成年幸存者中非常普遍。儿童癌症治疗与胰岛素敏感性适应性体育活动（APACIS）研究的目的是调查早在诊断时开始的两种运动方案对代谢状况和身体健康的影响。
APACIS是一项试验，纳入所有儿科癌症诊断时的儿童，这些儿童被随机分配到软组（进行低强度体育活动）或强组（进行混合高强度运动）。两个方案均至少每周进行两次，每次30至60分钟，为期6个月，并根据儿童的健康状况进行调整，随访18个月。主要目标是两组在0、3、6、12和24个月时通过胰岛素抵抗稳态模型评估（HOMA-IR）测量的胰岛素敏感性变化。次要目标包括0、3、6、12和24个月时胆固醇、甘油三酯和皮质醇血液水平的变化、营养不良状态、心肺适能（基于6分钟步行试验的峰值摄氧率）、柔韧性（坐立前屈柔韧性试验）、脂肪量分布（腰臀比）以及通过问卷评估的身体活动水平。还将通过整合检测150种代谢物、代谢途径富集和网络映射的综合流程来评估不同患者组的治疗期间代谢适应性。这种方法将通过对肠道和口腔微生物群的分析进行补充，以确定受治疗影响的物种以及运动对这些毒性的影响。
APACIS研究采用一种创新方法，即从诊断开始早期实践，调查进行低强度与高强度运动的癌症儿童的代谢、运动和营养影响。它将有助于在儿科癌症治疗期间更好地个性化体育活动处方。
该研究已于2022年11月7日在ClinicalTrials.gov上注册（NCT05383092）。
