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Childhood CancerPaNACHENCT06869005

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

An observational study of Childhood Cancer and Nausea with Vomiting Chemotherapy-Induced, run by Rennes University Hospital at 5 sites in France.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 4 to 18 years
What is being tested?
BARF scale
How many people
150 participants
Where
5 sitesFrance
Study dates
Mar 2025to Jul 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Direction de la Recherche et de l'innovation contact

0299282555

dri@chu-rennes.fr

5 sites in 1 country

France5 sites
  • CHU Angers

    Angers, France, 49933

    Rebecca VINAS JOLLY

  • CHU Caen FEH

    Caen, France, 14033

    Alexandra LAIGNEL

  • Rennes University Hospital

    Rennes, France, 35000

    Claude Pellen, 0299282555, claude.pellen@chu-rennes.fr

    Direction de la Recherche et de l'innovation, 0299282555, dri@chu-rennes.fr

  • Institut de Cancérologie de l'Ouest René Gauducheau

    Saint-Herblain, France, 44800

  • CHU Tours Hôpital Clocheville

    Tours, France, 37044

    Anaïs COUTANT

Other trials in France

About this study

Official title: Prévoir Les NAusées Et Vomissements CHimio Ou Radio-induits Chez Les Enfants/adolescents Traités Pour Un Cancer

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.

Read more

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).

Read the detailed description

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.

  • Several studies have focused on the prevention and relief of CVRN, a major side effect of cancer treatment. The importance of primary prevention of CVRN, before starting the first treatment sequence, has been highlighted.

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.

  • Finally, several observations made in different pediatric oncohaematology units, have highlighted a significant discrepancy between caregivers' perception of the CVRN symptom and the patient's own experience. These studies also highlight the existence of NV assessment scales, validated in pediatrics, but little known by professionals and therefore rarely used.

In practice:

  • Currently, in pediatric onco-hematology, there is no real management of CVRN. Each team refers to a "local" procedure, and its application is often "left" to the discretion of each caregiver (prescription "if necessary"). A review of practices and therapeutic recommendations of the Support Care Committee of the SFCE (Société Française de lutte contre les Cancers et Leucémies des Enfants et adolescents) have recently been published.
  • Relief of CVRN using non-medicinal techniques (hypnosis, acupuncture, laser, aromatherapy...) is also a heterogeneous practice (depending on specific professional skills), not evaluated in pediatrics.

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)

  • Self-assessment of NV perceived by the children/adolescent using the BARF scale (BAxter Retching Faces). This scale, graded from 0 to 10, shows 6 increasingly nauseous faces. It has been validated in pediatrics.

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.

Being tested
BARF scale
Keywords
Childhood Cancer, Chemo- or Radiation-induced Nausea and Vomiting (CVRN),, BARF scale, PaNACHE score
Medical subject headings
Neoplasms, Vomiting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BARF scaleOther

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: Up to 6 weeks.

Secondary outcomes (2)
  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).

    Measured: 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.

    Measured: Up to 6 weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2025
  2. Study startMar 2025 (estimated)
  3. Primary completionMay 2026 (estimated)
  4. Study completionJul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06869005
Sponsor's protocol ID
35RC21_9789_PaNACHE
Acronym
PaNACHE
Status last verified
Mar 2025
First submitted
19 Jun 2024
Last updated
11 Mar 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Childhood Cancer and Nausea with Vomiting Chemotherapy-Induced, run by Rennes University Hospital at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Claude Pellen (0299282555, claude.pellen@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Develop a multifactorial score to evaluate the risk of CVRN in children/adolescents treated for cancer (PaNACHE score). (time frame: Up to 6 weeks.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2025.

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