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NCT05606588: PrepAIR

Preventing Sensory and Motor Dysfunctions in Children Receiving Neurotoxic Chemotherapy

Status unknown NA Last updated 4 November 2022
What this trial tests

NA trial testing Playful sensorimotor training in Chemotherapy-induced Peripheral Neuropathy in 131 participants. Status unknown.

Timeline
1 December 2022
Primary endpoint
31 March 2025
31 March 2026

Quick facts

Lead sponsorUniversity of Basel
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment131
Start date1 December 2022
Primary completion31 March 2025
Estimated completion31 March 2026
Sites2 locations across Switzerland

Drugs / interventions tested

Conditions studied

Sponsor

University of Basel

Who can join

Adults 6 to 18, any sex, with Chemotherapy-induced Peripheral Neuropathy or Pediatric Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Chemotherapy-induced Peripheral Neuropathy

Currently open trials in the same condition.

Other University of Basel trials

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Data sources for this page

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