Prévoir Les NAusées Et Vomissements CHimio Ou Radio-induits Chez Les Enfants/adolescents Traités Pour Un Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 5
- 主要终点
- Develop a multifactorial score to evaluate the risk of CVRN in children/adolescents treated for cancer (PaNACHE score).
研究概览
简要总结
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).
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Develop a multifactorial score to evaluate the risk of CVRN in children/adolescents treated for cancer (PaNACHE score).
时间窗: 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).
次要结局
- 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.)