RecruitingNot ApplicableNCT05606588

Preventing Sensory and Motor Dysfunctions in Children Receiving Neurotoxic Chemotherapy

Preventing Sensory and Motor Dysfunctions in Children Receiving Neurotoxic Chemotherapy - a Randomized Controlled, Multi-center Trial


Sponsor

University of Basel

Enrollment

131 participants

Start Date

Dec 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The investigators would like to conduct a prospective, multicenter, two-armed trial (RCT with follow-up). Patients will be recruited from 7 centers (CH/D). All patients (and their guardians) scheduled to receive chemotherapy containing either a platinum derivate or vinca-alkaloid, will be asked to participate. Willing patients will then be randomized either into an intervention group or a control group. Patients in the intervention group will perform a standardized, age-adjusted, specific playful sensorimotor training (SMT) program twice a week for the duration of their medical therapy, 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 therapy. Data will be assessed at 3-4 time points: Prior to chemotherapy (baseline T0), after 12 weeks (T1), after completion of therapy for children that are treated \>3 months (Tp) and after 12 months follow-up (T3). Additionally, status of Chemotherapy-induced peripheral neuropathy (CIPN) reported symptoms will be monitored twice in-between (6 weeks). The investigators hypothesize that less children in the intervention group will develop symptoms of CIPN (TNS score) with its debilitating side-effects. Furthermore, children in the intervention group will be able to maintain relevant motor and sensory functions and their associated physical functions which will enable them to receive their planned medical therapy but also to stay on the age-appropriate motor development level, improve their quality life and enhance social reintegration after therapy.


Eligibility

Min Age: 6 YearsMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether special exercises and training can help prevent nerve and movement problems (called neuropathy) in children who receive certain chemotherapy drugs known to damage nerves, such as platinum-based drugs (like cisplatin) or vinca alkaloids (like vincristine). **You may be eligible if...** - You are between 6 and 18 years old - You have been diagnosed with a tumor - You are scheduled to receive neurotoxic chemotherapy (platinum-based or vinca alkaloid type) **You may NOT be eligible if...** - You already have a nerve condition (neuropathy) from another cause, such as diabetes - You have a disability or language barrier that prevents understanding the study instructions or consent form (German language required) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALPlayful sensorimotor training

For the max. duration of the first in-hospital phase (3weeks), all children will receive supervised training. When children go home they will be supplied with a manual, specific exercises and the necessary training devices. Regular supervision will allow to ensure that the training is performed at maximum benefit. Each session will last for about 20 to 30 minutes in total, including a child-specific warm-up and cool-down. The children will be asked to maintain balance in a previously acquired "short-foot-position", knees slightly flexed (30°), without shoes. Training will consist of 5 playful balance exercises chosen from a standardized pool of exercises according to the child's age, with increasing difficulty in order to allow for individual, optimal progression. Each of the 5 exercises will contain of 5 repetitions for 10sec. allowing for a 20sec. rest in between each set and a 1min rest between each exercise in order to avoid neural fatigue.


Locations(2)

Kantonspital Aarau

Basel, Switzerland

UKBB Kinderspital

Basel, Switzerland

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NCT05606588


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