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Cachexia and Gut Microbiota in Patients With Breast Cancer Receiving Home Care
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.
Official title: Evaluation of Cancer Cachexia and Analysis of Gut Microbiota in Patients With Breast Cancer Receiving Home Care
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
140
Start Date
2026-06-01
Completion Date
2028-08-31
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
Probiotic Mixture
Participants assigned to this intervention will receive an oral probiotic mixture twice daily for 12 weeks in addition to their usual oncologic treatment and supportive care. The probiotic mixture will be administered in sachets and taken orally twice daily for 12 weeks.
Placebo
Participants assigned to this intervention will receive a placebo orally twice daily for 12 weeks in addition to their usual oncologic treatment and supportive care. The placebo will be provided in sachets identical in appearance, taste, and administration schedule to the probiotic mixture and will contain no active bacteria.