Predict CHimio-or Radiation-induced NAusea and Vomiting in Children/adolescents Treated for Cancer
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-18
SponsorRennes University Hospital
About this trial
Chemo- or radiation-induced nausea and vomiting (CRVN) is one of the most frequent and feared side effects.
It is a symptom that is few or not at all evaluated. There is a significant discrepancy between the perception of the CRVN symptom by caregivers and the patient's own experience.
At present, there is no real consensus to manage CRVN with medication, and CRVN relief is also the subject of heterogeneous practices. The importance of primary prevention of CRVN, before starting the first treatment sequence, has been highlighted to optimize the action of antiemetic treatments and limit the risk of anticipated nausea and vomiting (NV).
The investigators' objective is to objectively assess the risk of CRVN in children/adolescents treated for cancer (and thus effectively prevent this symptom).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Treated in a pediatric onco-hematology center in the GOCE (Grand Ouest Cancer Enfant) inter-region;
Receiving chemotherapy or radiotherapy;
Minor (under 18 years): At least one parent has been informed of the protocol and has not expressed opposition to the child's participation in the study
Adult (more than 18 years): Having received information about the protocol and not having expressed opposition to participating in the study
Disqualifiers
Patients or legal representatives with French understanding difficulties.
Patients or legal representatives subject with legal protection (safeguard of justice, curatorship, guardianship) or deprived of liberty.
Trial population
In the Grand Ouest region, around 400 children/adolescents (aged 0-18) are diagnosed with cancer every year. A sample of 150 subjects is expected for this research (involving 5 of the 10 GOCE collaborating centers). This sample will be used to create a score including around ten variables (Peduzzi 1995). The distribution of the number of inclusions is adapted to the recruitment and activity (chemotherapy or radiotherapy) of each of the 5 centers participating in this study.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
BARF scale
Other interventionBARF Scale, validated in paediatrics, is graduated from 0 to 10 and shows 6 increasingly nauseous faces. A child/adolescent will be considered "at risk of NV" if he/she declares a score greater than or equal to 4 out of 10 on at least one of the 4 observation times. This scale can be used by the child him/herself, from the age of 4; or by a close adult, usually present at the child's side during treatment.
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Develop a multifactorial score to evaluate the risk of CVRN in children/adolescents treated for cancer (PaNACHE score).
The primary outcome is a score based on : * Dependent variable, binary, corresponding to self-assessment of NV perceived by the child/adolescent with the BARF Scale. This scale, validated in pediatrics, is graduated from 0 to 10 and shows 6 faces of increasing nausea. A child/adolescent will be considered "at risk of NV" if they report a score greater than or equal to 4 out of 10 on at least one of the 4 observation times. * Predictive variables, likely to influence NV: Individual variables (age, sex, history of NV, etc.) and treatment-related variables (type of chemotherapy, area and dose of irradiation).
Time frame
Up to 6 weeks.Secondary outcomes
1
Evaluate the concordance between the hetero-assessment of NV perceived by caregivers and the self-assessment of NV experienced by the patient.
In order to objectify professional practices, the child/adolescent's self-assessment of perceived NV (via the BARF Scale) will be compared with the caregiver's hetero-assessment (via the same BARF Scale) compared with caregiver hetero-assessment (using the same BARF Scale).
Time frame
Up to 6 weeks.2
Describe the management methods (preventive and/or curative; medicinal and/or non-medicinal) for CRVN, throughout the treatment phase.
Management methods (preventive and/or curative; medication and/or non-medication) for CRVN will be recorded for each patient, at each of the 4 observation times specified in the protocol.
Time frame
Up to 6 weeks.Sponsors and contacts
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Source ClinicalTrials.gov
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