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临床试验/NCT04847908
NCT04847908已完成不适用

Changes in Metabolite Concentrations After a Single High-intensity Interval Exercise Intervention During Treatment for Childhood Cancer - A Pilot Study

Technical University of Munich2 个研究点 分布在 1 个国家目标入组 11 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
11
试验地点
2
主要终点
Changes in adrenaline concentration

研究概览

简要总结

Observational studies report associations between physical activity and survival in some types of adult cancer. In addition, some exercise-induced molecules such as catecholamines (e.g., adrenaline) are known to change cancer cell signalling, proliferation and have been linked to clinical outcomes such as survival. The aim of this study is to analyse changes in adrenaline concentration with a single high-intensity interval exercise intervention on a cycle ergometer in children and adolescents during treatment for cancer and to examine the feasibility of the study concept.

详细描述

Exercise is generally recommended as an adjunct therapy for adult cancer patients as it counteracts the adverse effects of cancer and its treatment. According to epidemiological data, exercise is also associated with a reduced risk of tumour developement and an improval of survival in some tumours. However, the underlying mechanisms by which exercise affects tumour cells are poorly understood in adult cancer patients and mostly unknown in children. Recent studies demonstrate anti-cancer effects of exercise-induced adrenaline through natural killer cell mobilisation and Hippo signalling. In addition, several exercise-induced molecules such as catecholamines (e.g., adrenaline) are known to change cancer cell signalling, proliferation and have been linked to clinical outcomes such as survival. The aim of this pilot study is the analysation of exercise-induced changes in adrenaline concentration in childhood cancer patients and to show feasibility of the study concept. Following recruitment within the first and third cycle of chemotherapy and consent for study participation, all recruited patients perform a single high-intensity interval exercise intervention on a cycle ergometer. Intensity of the intervals is examined both subjectively via a scale for rate of perceived exertion and objectively via changes in lactate concentration pre- and post-exercise as well as heart rate monitoring. Blood samples are taken by trained personnel staff and prepared for processing (centrifuged, snap-frozen). Changes in adrenaline concentration are measured with a commercial ELISA kit. For further identification of metabolites that change with exercise, a non-biased mass spectrometry metabolomics analysis will be used.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
6 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • newly diagnosed pediatric cancer or relapse
  • aged 6-18 years
  • between the first and third cycle of chemotherapy
  • diagnosis and treatment at the Kinderklinik München Schwabing, Department of Paediatrics and Children's Cancer Research Centre, Technical University of Munich
  • German language
  • informed consent as documented by signature

排除标准

  • Any medical contraindication with respect to a high-intensity interval exercise intervention (e.g., cardiovascular complications, comorbidities, bleeding risk, pain, infection, nausea, orthopedic impairment of the lower extremities)
  • inability to follow the procedures and understand the intervention and assessment of the study, e.g., due to cognitive impairment, language problems, psychological disorders etc.

结局指标

主要结局

Changes in adrenaline concentration

时间窗: Pre-exercise (at rest, t0) and post-exercise (within 3 min, t1)

Blood samples are collected at rest pre-exercise (t0) and post-exercise (t1) via a central catheter and prepared for processing by trained personnel (centrifuged, snap-frozen). Both at t0 and t1, 4,9ml blood are taken for adrenaline and lactate concentration (see secondary outcomes). Serum adrenaline concentration is measured with an ELISA kit in mmol/l.

次要结局

  • Heart rate(Pre-exercise (at rest, t0), during high-intensity interval exercise intervention and post-exercise (within 3 min, t1))
  • Feasibility of the study concept(Through study completion, on average 14 days)
  • Lactate concentration(Pre-exercise (at rest, t0) and post-exercise (within 3 min, t1))
  • Physical activity before diagnosis(Once, pre-intervention)

研究者

发起方
Technical University of Munich
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sabine Kesting

Dr. rer. medic

Technical University of Munich

研究点 (2)

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