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Clinical Trials in France / NCT06869005
Starting soon Observational

Predict CHimio-or Radiation-induced NAusea and Vomiting in Children/adolescents Treated for Cancer

NCT06869005 · tracked via the Priya Life Science France tracker
Sponsor
Rennes University Hospital
Phase
Observational
Started
2025-03
Last updated
2025-03-11

Condition(s) studied

Childhood CancerNausea with Vomiting Chemotherapy-Induced

Investigational drug(s) / intervention(s)

BARF scale

BARF scale: BARF 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.

Study summary

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

Sex
ALL
Min age
4 Years
Max age
18 Years
Healthy volunteers
No
Inclusion Criteria: * Treated in a pediatric onco-hematology center in the GOCE (Grand Ouest Cancer Enfant) inter-region; * Receiving chemotherapy or radiotherapy; * According to patient age : * 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 Exclusion Criteria: * 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.

Primary outcome measure(s)

  • Develop a multifactorial score to evaluate the risk of CVRN in children/adolescents treated for cancer (PaNACHE score). — Up to 6 weeks.
    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).

Trial sites (5)

FacilityCityRegionStatus
CHU Angers Angers France
CHU Caen FEH Caen France
Rennes University Hospital Rennes France
Institut de Cancérologie de l'Ouest René Gauducheau Saint-Herblain France
CHU Tours Hôpital Clocheville Tours France

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Other trials for the same condition

Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation Recruiting
Adhesion of Children and Adolescents Treated for Cancer to Personalized Support in Adapted Physical Activity Program Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06869005 on ClinicalTrials.gov ↗ ← All trials in France