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

NCT06869005 | Not Yet Recruiting

• 1 other identifier: 35RC21_9789_PaNACHE
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 5

Brief 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).

Conditions

Childhood Cancer; Nausea with Vomiting Chemotherapy-Induced

Keywords

Childhood Cancer; Chemo- or Radiation-induced Nausea and Vomiting (CVRN),; BARF scale; PaNACHE score

Outcome Measures

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).

  Up to 6 weeks.

Secondary Outcomes (2)

• Evaluate the concordance between the hetero-assessment of NV perceived by caregivers and the self-assessment of NV experienced by the patient.

  Up to 6 weeks.

• Describe the management methods (preventive and/or curative; medicinal and/or non-medicinal) for CRVN, throughout the treatment phase.

  Up to 6 weeks.

Interventions

BARF scale OTHER

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.

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rennes University Hospital: lead

Study Sites (5)

CHU Angers

Angers, France, 49933, France

Location

CHU Caen FEH

Caen, France, 14033, France

Location

Rennes University Hospital

Rennes, France, 35000, France

Location

Institut de Cancérologie de l'Ouest René Gauducheau

Saint-Herblain, France, 44800, France

Location

CHU Tours Hôpital Clocheville

Tours, France, 37044, France

Location

MeSH Terms

Conditions

Neoplasms; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maïna LETORT-BERTRAND

  CHU Rennes Hôpital Sud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Claude Pellen

CONTACT

0299282555; claude.pellen@chu-rennes.fr

Direction de la Recherche et de l'innovation

CONTACT

0299282555; dri@chu-rennes.fr

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: March 11, 2025
• Study Start: March 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: July 1, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (5)