Trial Title:
Preventing Sensory and Motor Dysfunctions in Children Receiving Neurotoxic Chemotherapy
NCT ID:
NCT05606588
Condition:
Chemotherapy-induced Peripheral Neuropathy
Pediatric Cancer
Conditions: Official terms:
Peripheral Nervous System Diseases
Conditions: Keywords:
Cancer
Lymphoma
Leukemia
Non-Hodgkin Lymphoma
Children
Exercise
Chemotherapy-induced peripheral neuropathy
CIPN
Sensorimotor Training
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
This study will follow a prospective, multicenter, two-armed, randomised, controlled,
assessor-blinded trial trial (RCT with follow-up).
Primary purpose:
Prevention
Masking:
Single (Outcomes Assessor)
Masking description:
All assessors will be blinded and participants will only be told the result of their
randomization after the baseline assessment. For the following assessments patients and
guardians will be instructed prior to the assessment not to reveal the arm they are in.
Assessors are instructed to converse as little as possible outside the friendly
instructions. Assessors and trainers will participate in separate study meetings and
cannot speak to each other regarding patient matters.
Intervention:
Intervention type:
Behavioral
Intervention name:
Playful sensorimotor training
Description:
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.
Arm group label:
Intervention group
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.
Detailed description:
Modern therapy has improved survival for children with cancer. However, treatment has
unintended consequences. Depending on the neurotoxic agent (platinum derivates or
vinca-alkaloids), 52%-100% of children develop a peripheral neuropathy. Diagnosis is
underreported and its impact as potentially initial cause for many sensory and motor
symptoms underestimated. The severe symptoms such as loss of sensation, numbness, pain,
absent reflexes as well as loss of balance control not only delays motor development
milestones such as walking, running, jumping or climbing, diminishing children's quality
of life and affecting their social reintegration, but is also of high clinical relevance.
Additionally, recovery is poor and there are currently no effective options to prevent or
treat the symptoms of Chemotherapy-induced peripheral neuropathy (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=131 will be recruited from 7 centers: University
Children's Hospital of Basel, the Inselspital Bern, Kantonsspital Aarau, Children
Hospital for Eastern Switzerland St. Gallen, University Children Hospital Freiburg and
the National Center for tumor diseases (NCT), University Children Hospital Heidelberg,
Charité Berlin. 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 (CG). 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 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- All tumor patients, aged 6-18 years, who are scheduled to receive neurotoxic
chemotherapy with a platinum-derivate or vinca- alkaloid (e.g. vincristine,
vinblastin mono, carboplatinum, cisplatin).
Exclusion Criteria:
- Exclusion criteria are known neuropathies of other cause (e.g. diabetes),
disabilities or lack of German language that prevent the understanding of the
informed consent as well as the instructions for training.
Gender:
All
Minimum age:
6 Years
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Kantonspital Aarau
Address:
City:
Basel
Zip:
4056
Country:
Switzerland
Status:
Not yet recruiting
Contact:
Last name:
Jeanette Greiner, Dr
Facility:
Name:
UKBB Kinderspital
Address:
City:
Basel
Zip:
4056
Country:
Switzerland
Status:
Recruiting
Contact:
Last name:
Nicolas Von Der Weid
Phone:
617042995
Start date:
December 1, 2022
Completion date:
March 31, 2026
Lead sponsor:
Agency:
University of Basel
Agency class:
Other
Collaborator:
Agency:
Insel Gruppe AG, University Hospital Bern
Agency class:
Other
Collaborator:
Agency:
Kantonsspital Aarau
Agency class:
Other
Collaborator:
Agency:
Ostschweizer Kinderspital
Agency class:
Other
Collaborator:
Agency:
University Hospital Heidelberg
Agency class:
Other
Collaborator:
Agency:
University Hospital Freiburg
Agency class:
Other
Collaborator:
Agency:
Krebsforschung Schweiz, Bern, Switzerland
Agency class:
Other
Collaborator:
Agency:
Clinical Trial Unit, University Hospital Basel, Switzerland
Agency class:
Other
Collaborator:
Agency:
Charite University, Berlin, Germany
Agency class:
Other
Collaborator:
Agency:
National Center for Tumor Diseases, Heidelberg
Agency class:
Other
Source:
University of Basel
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05606588
