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临床试验/NCT06643026
NCT06643026已完成不适用

Sensory Evaluation of Taste and Smell in Oncology

Hospices Civils de Lyon3 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2024年11月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
69
试验地点
3
主要终点
Proportion of patient with changes in food preferences of digestive cancer patients at the end of the first cycle of chemotherapy.

研究概览

简要总结

Nutritional status is a major issue in the management of cancer patients. Forty to 60% of patients are undernourished at diagnosis. This undernutrition has a direct impact on patients' health and quality of life, with a reduction in survival associated with an increase in the risk of toxicity from anti-cancer treatments (chemotherapy, radiotherapy, surgery), the risk of infection and the risk of hospitalization. Thus, it is estimated that 10-20% of cancer patients die from the consequences of their undernutrition rather than from the tumor itself (Muscaritoli et al. 2021).

It is therefore recommended to systematically implement a multimodal nutritional intervention in cancer patients (recommendations of the learned societies ESPEN, ESMO and ASCO), combining nutritional support (oral and/or enteral and/or parenteral) with physical exercise (Muscaritoli et al. 2021). However, despite the systematic provision of dietary management, the effectiveness of nutritional interventions varies from patient to patient in terms of nutritional status, quality of life and overall survival (Cintoni et al. 2023).

Among the factors impacting patient compliance with dietary measures and their efficacy, sensory alterations occurring under chemotherapy potentially have a major impact (Drareni et al., 2019).

Indeed, the vast majority of patients describe an alteration in tastes and smells after starting chemotherapy treatment. However, few studies have focused on the specific parameters associated with these alterations. The aim of this study is to prospectively assess changes in sensory perceptions and eating habits in patients undergoing chemotherapy for digestive cancer at the start of treatment and after the first cycle of chemotherapy, and to correlate these alterations with patients' nutritional profile and clinical course.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Able to complete the proposed questionnaires
  • Patients over 18 years of age
  • Non-opposed patients
  • Digestive cancers starting chemotherapy and/or immunotherapy
  • Able to eat by mouth

排除标准

  • Concomitant treatment for a non-digestive cancer (excluding basal/spinocellular carcinoma and chronic haemopathy)
  • Previous ENT surgery (face/neck)
  • Exclusive enteral feeding (nasogastric tube, gastrostomy) or parenteral nutrition
  • Previous chemotherapy/immunotherapy < 5 years
  • Individuals deprived of liberty by a judicial or administrative decision

研究组 & 干预措施

Patients with digestive cancer traited by chemotherapy

Patients with malignant digestive tumors receiving active chemotherapy

干预措施: Food preference (Other)

Patients with digestive cancer traited by immunotherapy

Patients with malignant digestive tumors receiving immunotherapy only

干预措施: Food preference (Other)

结局指标

主要结局

Proportion of patient with changes in food preferences of digestive cancer patients at the end of the first cycle of chemotherapy.

时间窗: At two month (end of the first cycle of chemotherapy/immunotherapy)

Proportion of patients with 'altered' food preferences at the end of the first cycle of chemotherapy, with alteration defined as a reported decrease in appreciation for at least 30% of foods compared to before chemotherapy initiation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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