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临床试验/NCT03334162
NCT03334162暂停不适用

Playful Sensorimotor Training to Reduce the Symptoms of Chemotherapy-induced Peripheral Neuropathy in Pediatric Brain Tumor Patients- a Randomized Controlled Trial

University of Basel2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年5月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
暂停
入组人数
20
试验地点
2
主要终点
Ped-mTNS score (assesses the change in the severity of CIPN symptoms)

研究概览

简要总结

Chemotherapy-induced peripheral neuropathy (CIPN) is a highly prevalent and clinically relevant side-effect of cancer treatment. The severe symptoms such as loss of sensation, numbness, pain, absent reflexes or loss of balance control not only diminish children's quality of life but also affect the medical therapy. To date, there are no effective treatment options to reduce the symptoms of CIPN. Promising results have so far been achieved with specific exercise interventions.

The investigators would therefore like to conduct a prospective, multicenter, two-armed trial (RCT with follow-up). Patients (N=20) will be recruited from the Hospital for Children and Adolescents, Kantonsspital Aarau. Prior to randomization, all primarily eligible patients that have received a platin derivate or vinca-alkaloid, will be screened for symptoms of CIPN. Eligible patients with a neurologically confirmed CIPN will then be randomized either into an intervention group or a control group (CG). Patients in the intervention group will perform a standardized, age-adjusted, specific playful sensorimotor training (SMT) program twice a week for 12 weeks in addition to usual care, while the control group receives treatment as usual. The CG will be given the opportunity to participate in the intervention after study completion. Data change will be assessed at 3 time points: At baseline (T0), after 12 weeks (post intervention testing, T1), and after 12 weeks of follow-up (T2). Primary endpoint is the Ped-mTNS score in order to subjectively as well as objectively assess the severity of CIPN symptoms. It contains a short questionnaire as well as more objective parameters such as light touch sensation, pin sensibility, vibration sensibility, deep tendon reflexes and muscular strength. Additionally, the CIPN symptom pattern will be assessed via nerve conduction studies, CIPN related pain, dorsiflexion and knee extension as well as postural control. Furthermore, investigators will be evaluating patients' level of physical activity, walk to run transition time, lower limb power as well as patients integration in physical education (PE) in school and sport club activities. The investigators hypothesize that patients in the intervention group will be able to reduce relevant symptoms of CIPN, improving related physical functions and enhancing children's social reintegration.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

盲法说明

All investigators dealing with the assessments (neurological and sport scientific) and data are blinded, solely the patient as well as the training staff can't be blinded due to the nature of an exercise interventional study.

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

  • patients with a central nervous system (CNS) tumor
  • age: ≥ 6 and ≤ 18 years
  • neurotoxic chemotherapy treatment is completed 3 months to 2 years ago
  • neurotoxic chemotherapy comprised a platinum-derivate or vinca-alkaloid (low grade gliomas: vincristine/carboplatin or vinblastin mono and embryonal tumors as well as ependymomas: cisplatin/ lomustine and vincristine or cyclophosphamide/ carboplatin/ vincristine/ etoposide)

排除标准

  • neuropathies of other cause (e.g. diabetes)
  • disabilities
  • lack of German language that prevent the understanding of the informed consent as well as the instructions for training

研究组 & 干预措施

Intervention group

Experimental

Patients in the intervention group will perform a standardized, age-adjusted, specific playful sensorimotor training (SMT) program twice a week for 12 weeks in addition to usual care.

干预措施: Sensorimotor training (Behavioral)

Control group

No Intervention

Children in the control group will receive treatment as usual. The control group will be given the opportunity to participate in the intervention after study completion

结局指标

主要结局

Ped-mTNS score (assesses the change in the severity of CIPN symptoms)

时间窗: Delta of Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).

The Ped-mTNS Score comprises the patient reported outcome, in accordance with pharmaceutical studies to reduce the symptoms of CIPN as well as an objective clinical test battery, resulting in an overall score. The questionnaire contains questions regarding sensory, functional and autonomic symptoms of CIPN and will be used to document and assess the severity of the subjective peripheral neuropathy (PNP) symptoms. The clinical test battery contains light touch sensation, evaluated with Semmes-Weinstein-monofilaments, pin sensibility (MediPin), vibration sensibility assessed with a biothesiometer, deep tendon reflexes of Achilles and patellar tendons and muscular strength examined by a manual muscle test.

次要结局

  • Postural control(Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).)
  • Knee extension strength(Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).)
  • Participation in PE as well exercise-related leisure activities(Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).)
  • short clinical test battery for CIPN(Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).)
  • lower limb power(Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).)
  • CIPN-related pain(Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).)
  • Priority of side-effects(Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).)
  • Dorsiflexion function(Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).)
  • Walk to run transition time:(Data will be assessed at 3 time points: At baseline (T0), post assessment after 12 weeks of intervention (T1) and after 12 weeks of follow-up (T2).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Fiona Streckmann

Principal Investigator

University of Basel

研究点 (2)

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