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临床试验/CTRI/2025/07/091835
CTRI/2025/07/091835尚未招募不适用

Microbial and metabolic determinants of chemotherapy induced nausea and vomiting :A systems-level multi-omics investigation into gut-derived biological pathways influencing chemotherapy induced nausea and vomiting in stem cell transplant patients-A prospective observational study

ALL INDIA INSTITUTE OF MEDICAL SCIENCES1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2025年8月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
106
试验地点
1
主要终点
To find the association between baseline microbiome and chemotherapy induced nausea vomiting in patients undergoing hematopoietic stem cell transplant

研究概览

简要总结

Chemotherapy induced nausea and vomiting continues to be a significant distressing complication in patients undergoing hematopoietic stem cell transplantation. The prevalence of break through CINV in up to half of such patients not only impairs quality of life but also affects treatment, nutritional status, recovery outcomes. Recent insights into the gut brain axis suggests that the gut microbiome plays a critical role in modulating chemotherapy related toxicities, including emetic responses. Chemotherapy disrupts the gut microbial ecosystem, alters metabolite production and promotes inflammation. All of which may influence nausea and vomiting pathways. While emerging studies in solid tumors highlight the potential link between microbiota and CINV, there is currently no data specific to the hematopoietic stem cell transplantation. Given this context, investigating the microbiome CINV relationship in these patients is both timely and necessary. This study will fill a critical knowledge gap by identifying microbiota and metabolic signatures predicting of CINV, laying the groundwork for future personalized, microbiome targeted anti emetic interventions that may ultimately improve clinical outcomes and patient well being during transplantation.

研究设计

研究类型
Observational

入排标准

年龄范围
12.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patient willing to participate in the study and to provide written informed consent
  • Patients aged 12yrs to 65 yrs.
  • undergoing Conditioning for autologous or allogenic hematopoietic stem cell transplant
  • Weight more than or equal to 30 kg.

排除标准

  • Hepatic dysfunction (aminotransferase/alanine aminotransferase more than 3 times of upper normal limit, serum bilirubin more than 2 times of upper normal limit) 2) Patients with cardiac arrhythmia, uncontrolled congestive heart failure, or acute myocardial infarction within the previous 6 months 3) Preexisting psychiatric disorders 4) Severe renal impairment (GFR less than 50 ml/hr.
  • or creatinine more than 1.5 times upper normal limit) 5) Pregnant or lactating women 6) Refusal to participate in the study.

结局指标

主要结局

To find the association between baseline microbiome and chemotherapy induced nausea vomiting in patients undergoing hematopoietic stem cell transplant

时间窗: Baseline and at the end of 6 days from last day of conditioning regimen

次要结局

  • 1. To assess the association between the gut microbiome composition and the metabolomics profile with CINV(2. To evaluate the association between dietary intake and gut microbiome composition with CINV)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Dr Abhivandana Pallati

ALL INDIA INSTITUTE OF MEDICAL SCIENCES

研究点 (1)

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