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临床试验/NCT07260617
NCT07260617尚未招募不适用

Study of the Association Between the Composition of the Gut Microbiota and Nutritional Status in Patients Treated With Chemotherapy in Digestive Oncology

Hospices Civils de Lyon3 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2025年12月1日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
150
试验地点
3
主要终点
Difference in fecal microbiota composition, assessed by beta-diversity (Weighted UniFrac and Bray-Curtis) based on shotgun metagenomic data, between patients with severe, moderate, or no malnutrition evaluated at V1 and V2.

研究概览

简要总结

Nutritional status represents a crucial issue in the management of cancer patients, as between 40% and 60% of them suffer from malnutrition at the time of diagnosis. This condition worsens morbidity, increases treatment-related adverse effects, infections, and hospitalizations, and can lead to death in 10% to 20% of cases, independently of tumor progression. Anticancer treatments often exacerbate malnutrition due to their side effects, such as loss of appetite or taste alterations.

Although international guidelines (ESPEN, ESMO, ASCO) recommend a multimodal nutritional intervention combining nutritional support and physical activity. The effectiveness of these approaches varies among patients. This variability can be explained by several factors, including individual differences in dietary intake response, metabolic status, and digestive tolerance to treatments.

The intestinal and oral microbiota appear to be key cofactors in regulating these various parameters, influencing appetite, host metabolism, and intestinal absorption. Alterations in the microbiota-particularly a decrease in bacterial diversity and an increase in Candida albicans-have been associated with appetite loss and taste perception disorders, especially in patients with digestive cancers. Therefore, the intestinal microbiota constitutes a potential therapeutic and diagnostic target to improve nutritional strategies in oncology.

Interventions targeting the microbiota (such as probiotic supplementation or fecal microbiota transplantation) have already demonstrated an impact on nutritional parameters in preclinical models of malnourished cancer-bearing mice; however, clinical data remain scarce and limited.

The ONCONUTRIBIOTA-cohort study aims to characterize and investigate the oral and intestinal microbiota of patients initiating chemotherapy for digestive cancer, in relation to their nutritional status clinical characteristics and food preferences, in order to identify potential biomarkers or therapeutic targets to optimize their nutritional management.

Patients will be followed during two of their routine care visits: on the day of the first chemotherapy treatment and at the end of the first cycle of chemotherapy. During these visits, stool and saliva samples will be collected, completed by additional assessments including global quality of life and nutritional quality of life questionnaires, olfactory and gustatory tests, and measurements of parameters used to determine the presence of malnutrition, general health status and oncological evaluation.

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Difference in fecal microbiota composition, assessed by beta-diversity (Weighted UniFrac and Bray-Curtis) based on shotgun metagenomic data, between patients with severe, moderate, or no malnutrition evaluated at V1 and V2.

时间窗: at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy

The difference in fecal microbiota composition, measured by beta-diversity (Weighted UniFrac and Bray Curtis) from shotgun metagenomic data, between patients with severe, moderate, and no malnutrition assessed at V1 (before 1st cure of chemotherapy) and V2 (after the first cycle of chemotherapy). Malnutrition is defined according to GLIM recommendations by the combination of the etiological criterion of active neoplasia common to all patients included, associated with a phenotypic criterion (BMI, weight loss, sarcopenia according to a standardized method).

次要结局

  • Difference in oral microbiota composition before and after chemotherapy treatment(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)
  • Variation in the taxonomic and functional composition of the oral and fecal microbiota(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)
  • Fecal and oral metabolomic signatures associated with malnutrition status(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)
  • Correlation between taxonomic profiles and markers of nutritional status(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)
  • Change in nutritional parameters during chemotherapy(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)
  • Intra-individual variation in blood markers of nutritional status(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)
  • Change in sensory scores during chemotherapy(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)
  • Correlation between sensory scores and nutritional status markers(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)
  • Correlation between sensory scores and the composition of oral and fecal microbiota(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)
  • Correlation of patients' quality of life with the composition of oral and fecal microbiota(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)
  • Correlation between sensory scores and quality of life score(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)
  • Correlation between nutritional status markers and quality of life score(at pre-chimotherapy or after the 1st chimotherapy treatment and the end of the first cycle of chemotherapy)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (3)

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