An observational study in Childhood Cancer and Nausea with Vomiting Chemotherapy-Induced, sponsored by Rennes University Hospital. Not yet recruiting at 5 sites in France. Open to participants aged 4 Years to 18 Years. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Rennes University Hospital · Observational
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).
In France, around 2,500 cancers are diagnosed each year in children/adolescents (0-18 years) (INCa data for 2011-2014).
For around 90% of these cases, chemotherapy and/or radiotherapy are indicated. Today, pediatric onco-hematology teams are committed to both the efficacy of treatments (and continue the progress made over the last few the progress made in recent decades in terms of survival); and to optimize the quality of life. One of the key areas for improving patient experience is to reduce the toxicity of treatments, and to prevent and alleviate known side effects.
Among these toxicities, chemo- or radiation-induced nausea and vomiting (CRVN) are one of the most frequent and dreaded side effects.
In addition to the impact of nausea and vomiting (NV) on the quality of life of children/adolescents (possibly impacting therapeutic); CRVN can lead to serious metabolic complications (sometimes impacting optimal treatment).
Theoretical considerations:
Several publications have already described the mechanisms of CRVN. Various studies have highlighted individual factors (gender, age, etc.) influencing the occurrence of NV (including in children/adolescents); and a variable emetogenic potential depending on the type of chemotherapy or radiotherapy.
The interests are twofold: to optimize the action of antiemetic treatments (more effective preventively than after the onset of vomiting); and to limit the risk of anticipated NV during subsequent treatment sequences.
In practice:
In this context, the investigators were interested in the primary prophylaxis of NV; and wondered how to objectively assess the risk of CVRN in children/adolescents treated for cancer (and thus effectively prevent this symptom).
To meet this need, the project aims to develop a multifactorial score for assessing the risk of CVRN in children/adolescents treated for cancer (PaNACHE score).
The questioning at the origin of this project focused on considering the "NV" symptom in its different dimensions (sensory- emotional-cognitive-behavioral), such as the "pain" symptom. This approach enables us to base on validated models for assessing and managing pain in children/adolescents, centered in particular on the self-assessment of "patient experience".
The PaNACHE score is based on :
Assessment of various factors (individual and/or treatment-related) influencing NV (some of which have already been described in the literature)
It can be used by the child himself from the age of 4, or by a close adult who is usually present with the child during treatment.
Since several studies have highlighted a noticeable difference between the caregiver's perception of the CVRN symptom and the patient's own experience, the investigators feel it is important to take into account the child/adolescent's self-assessment of his or her feelings, and not simply the factual number of vomits and/or the caregiver's hetero-assessment of perceived nausea.
822 studies on the registry are indexed under Nausea; 104 are open to participants now.
This study's planned enrollment of 150 is below the median of 170 across 90 observational studies indexed under Nausea.
Browse Nausea studies →Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Exclusion Criteria:
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.
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.
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.
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.
Plan to share: No
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Rennes University Hospital