Evaluation of Optimised Early Management in the Context of Radiochemotherapy for Curatively Treated Squamous Cell Carcinoma of the Head and Neck
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 138
- 试验地点
- 7
- 主要终点
- Assessing of the impact of early multimodal management on weight loss measured between the inclusion consultation and 3 months post-treatment.
研究概览
简要总结
Post-operative concomitant radiochemotherapy is a treatment that is difficult to achieve for several reasons. First of all, and by definition, these patients have had recent surgery, most often accompanied by several weeks of hospitalization and weight loss. In addition, the functional recovery of feeding capacity is not always complete at the time of the start of irradiation. In addition, concomitant radiochemotherapy is responsible for very frequent radiomucitus which alters the feeding capacity of patients during treatment.
In total, the rate of complete radiochemotherapy (3 cures of cisplatin administered) varies from 50 to 70% depending on the studies, which were carried out in selected populations within the framework of an experimental clinical trial and without distinguishing between positive and negative Human Papilloma tumours . In our experience, in a population with a very high preponderance of non-Human Papilloma-related tumours and not selected by participation in an experimental trial, complete radiochemotherapy is only possible in about 40% to 50% of cases.However, the amount of cisplatin actually administered is correlated with overall survival. Therefore, it is logical to assume that increasing the number of patients receiving full treatment may result in increased survival.
While the need for nutritional care during radiotherapy is clearly established, its modality remains debated. Recently, a randomised study of 159 patients treated by radiotherapy (or radiochemotherapy) showed that the simple systematic prescription of oral food supplements (500 kcal/d) in addition to the usual dietary advice was associated with a lesser reduction in weight at the end of radiotherapy (main objective) but also with an improvement in the tolerance of the treatments. Overall, nutritional management during treatment varies greatly, ranging from simple dietary monitoring to prophylactic gastrostomy and the insertion of a nasogastric tube on demand during treatment. This heterogeneity of management found in the literature is also observed at the regional level. This project will also make it possible to propose a harmonized support strategy at the inter-regional level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, over 18 and under 75 years of age,
- •Worl Health Organisation score < 2,
- •Treatment for a localized squamous cell carcinoma of the head and neck for which a curative treatment by concomitant post-operative radiochemotherapy based on cisplatin is retained,
- •Having signed the informed consent,
- •Affiliate or beneficiary of a social protection scheme.
排除标准
- •History of other neoplastic disease less than 2 years old or progressive,
- •History of radiotherapy for head and neck cancer,
- •Contraindications to cisplatin,
- •Pregnant or breastfeeding woman,
- •Protected major (under guardianship or curatorship),
- •Patient participating in a therapeutic study
- •Patient unable to understand the study for any reason or to comply with the constraints of the trial
结局指标
主要结局
Assessing of the impact of early multimodal management on weight loss measured between the inclusion consultation and 3 months post-treatment.
时间窗: 3 months post treatment
Proportion of patients with at least 5% reduction in weight at 3 months post-treatment compared to the inclusion consultation
次要结局
- Assessing the impact of multimodal management on overall survival and progression-free survival at 18 months post-treatment(18 months post treatment)
- Assessing the impact of multimodal management on the percentage of patients receiving the full treatment as planned(1 month)
- Assessing the impact of multimodal management on the percentage of patients receiving level 3 analgesics during radio-chemotherapy and up to 3 months post-treatment(3 months post treatment)
- Assessing the impact of multimodal management on average weight loss(18 months post treatment)
- Medico-economic analysis of multimodal management using the cost-utility method(18 months post treatment)