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临床试验/NCT07653698
NCT07653698尚未招募不适用

Evaluation of Cancer Cachexia and Analysis of Gut Microbiota in Patients With Breast Cancer Receiving Home Care

Fondazione ANT Franco Pannuti ETS0 个研究点目标入组 140 人开始时间: 2026年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
140

研究概览

简要总结

This study aims to evaluate the possible association between cancer cachexia and Gut Microbiota (GM) in patients with Breast Cancer (BC) cared at home.

Cancer cachexia is a multifactorial condition causing weight loss, muscle loss, and reduced physical strength in people with cancer. Moreover, the study will also analyze whether different stages of cachexia are linked to changes in the GM.

The study will also explore whether a supplementation with a probiotic mixture for twelve weeks is associated with changes in the GM and participants' nutritional and clinical condition.

The effect of the probiotic mixture (experimental group) will be compared with a placebo (control group) to evaluate whether changes in the GM and in cachexia-related measures differ between the two groups.

Participants will:

  • Provide blood, stool, and urine samples to study the GM and biological markers.
  • Answer questionnaires about symptoms and quality of life.
  • Undergo assessments of nutritional status and body composition.

Participants eligible for the intervention will take either a probiotic mixture or a placebo for twelve weeks.

All study procedures will take place during home visits as part of the participants' regular home care program.

详细描述

Cancer cachexia is a multifactorial syndrome defined by an ongoing loss of skeletal muscle mass that cannot be fully reversed by conventional nutritional support and leads to a progressive functional impairment. Moreover, cachexia is characterized by involuntary weight loss, reduced food intake, systemic inflammation, and metabolic alteration. Its pathophysiology is characterized by a negative protein and energy balance driven by a variable combination of reduced food intake and abnormal metabolism. It is common in people with advanced cancer and is associated with lower quality of life, poorer functional status, and shorter survival. Cachexia syndrome can develop progressively through various stages - precachexia, cachexia, and refractory cachexia and its severity can be classified according to degree of depletion of energy stores and body protein in combination with degree of ongoing weight loss. Refractory cachexia, which is considered no longer reversible, represents a very advanced stage associated with progressive worsening of quality of life and severe hypercatabolism, with an expected survival of less than three months.

The Gut Microbiota (GM) is increasingly recognized as a possible factor involved in the development and progression of cancer cachexia. Alterations in the GM, often referred to as dysbiosis, may contribute to systemic inflammation, intestinal barrier dysfunction, altered nutrient metabolism, and loss of muscle mass. Previous studies have shown that people with cancer cachexia may have specific alterations in GM, including differences in the abundance of certain bacterial groups and lower production of anti-inflammatory metabolites such as short-chain fatty acids.

The association between alterations in the GM and the development of cancer cachexia suggests that modifying the GM to correct cachexia-related dysbiosis may lead to new integrative approaches for the management of this highly burdensome condition.

Recent studies suggest that Breast Cancer (BC) is associated with GM dysbiosis and that changes in GM composition and function may play a crucial role in tumor development and progression. In these studies, patients with BC frequently show a different GM composition compared with healthy individuals, including specific alterations in certain bacterial taxa and a reduction in microbial alpha diversity. However, limited data are available on the relationship between GM and cachexia in people with BC, especially among those receiving home-based supportive and palliative care.

Considering that BC is one of the most common cancers among women assisted by the home supportive and palliative care program, it is particularly important to identify strategies that may improve the quality of life of these patients. A simple and feasible option to support the nutritional and functional status of these particularly vulnerable patients could be probiotic supplementation. At present, to our knowledge, no studies have evaluated the effect of probiotic supplementation on cachexia status in patients with BC.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

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

入选标准

  • Female patients with Breast Cancer (BC)
  • Age ≥ 18 years
  • Able to understand the study objectives and provide written informed consent
  • Able to speak and understand Italian

排除标准

  • Antibiotic treatment within the previous 2 weeks
  • Use of probiotic supplements within the previous month
  • Artificial nutrition (enteral or parenteral)
  • Severe dysphagia, intestinal obstruction, or impaired gastrointestinal function
  • Diagnosis of dementia or cognitive impairment preventing understanding of the study information and/or provision of informed consent
  • Severe organ failure
  • Refusal to participate For the interventional phase: refractory cachexia and/or life expectancy of less than 6 weeks

研究者

发起方
Fondazione ANT Franco Pannuti ETS
申办方类型
Other
责任方
Sponsor

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