Playful Sensorimotor Training in Pediatric Brain Tumor Patients (RESET)

University of Basel

Status: Suspended

Conditions: Chemotherapy-induced Peripheral Neuropathy; Pediatric Brain Tumor; Sensorimotor Polyneuropathy; Pediatric Cancer

Treatments: Behavioral: Sensorimotor training

Study type: Interventional

Funder types: Other

Identifiers

NCT03334162

RESET-study

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 6 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

Intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: Sensorimotor training

Control group

No Intervention group

Description:

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