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NCT07653698
Cachexia and Gut Microbiota in Patients With Breast Cancer Receiving Home Care
Conditions: Breast Cancer, Cancer Cachexia
Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 140
Sponsor: Fondazione ANT Franco Pannuti ETS
Summary
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.
Eligibility Criteria
Inclusion Criteria
* 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
Exclusion Criteria
* 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
Source: ClinicalTrials.gov (NCT07653698). StuddyBuddy aggregates publicly available trial information.