Clinical trial NCT03334162: Playful Sensorimotor Training in Pediatric Brain Tumor Patients
Official title: Playful Sensorimotor Training to Reduce the Symptoms of Chemotherapy-induced Peripheral Neuropathy in Pediatric Brain Tumor Patients- a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Pediatric Cancer
Pediatric Brain Tumor
Chemotherapy-induced Peripheral Neuropathy
Sensorimotor Polyneuropathy
Keywords: Children
Adolescents
Cancer
brain Tumor
exercise
Chemotherapy-induced Peripheral Neuropathy
CIPN
Sensorimotor Training
Lead sponsor: University of Basel
Sponsor class: OTHER
Collaborators: name: Kantonsspital Aarau
First posted: 2017-11-07
Enrollment: 20
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This pilot study will follow a prospective, two-armed, randomized controlled design (RCT with follow-up)
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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

Primary outcomes:
measure: Ped-mTNS score (assesses the change in the severity of CIPN symptoms)
timeFrame: 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).
Secondary outcomes:
measure: short clinical test battery for CIPN
timeFrame: 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).
measure: Postural control
timeFrame: 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).
measure: Dorsiflexion function
timeFrame: 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).
measure: Knee extension strength
timeFrame: 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).
measure: lower limb power
timeFrame: 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).
measure: Walk to run transition time:
timeFrame: 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).
measure: CIPN-related pain
timeFrame: 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).
measure: Participation in PE as well exercise-related leisure activities
timeFrame: 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).
measure: Priority of side-effects
timeFrame: 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).
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Kantonspital Aarau
Study officials:
affiliation: University of Basel, Departement of Sport, Exercise and Health
name: Fiona Streckmann
role: PRINCIPAL_INVESTIGATOR
References: