Predict CHimio-or Radiation-induced NAusea and Vomiting in Children/adolescents Treated for Cancer
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: BARF scale.
- Кому может быть актуально
- Состояния в реестре: Childhood Cancer, Nausea with Vomiting Chemotherapy-Induced. Базовые параметры: 4 лет — 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Франция
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Prévoir Les NAusées Et Vomissements CHimio Ou Radio-induits Chez Les Enfants/adolescents Traités Pour Un Cancer
Обзор
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).
Подробное описание
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.
Вмешательства
- Другое 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.
Первичные конечные точки
- Develop a multifactorial score to evaluate the risk of CVRN in children/adolescents treated for cancer (PaNACHE score). [Срок оценки: Up to 6 weeks.]
Вторичные конечные точки (2)
- Evaluate the concordance between the hetero-assessment of NV perceived by caregivers and the self-assessment of NV experienced by the patient. [Срок оценки: Up to 6 weeks.]
- Describe the management methods (preventive and/or curative; medicinal and/or non-medicinal) for CRVN, throughout the treatment phase. [Срок оценки: Up to 6 weeks.]
Критерии участия
Критерии включения
- 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
Критерии исключения
- 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.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
Франция · 5 центров
- CHU Angers — Angers
- CHU Caen FEH — Caen
- Rennes University Hospital — Rennes
- Institut de Cancérologie de l'Ouest René Gauducheau — Saint-Herblain
- CHU Tours Hôpital Clocheville — Tours
Идентификаторы
NCT: NCT06869005 · 35RC21_9789_PaNACHE