About this trial
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
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Probiotic Mixture
- Placebo
Treatment groups
Locations
Sponsors and collaborators
Fondazione ANT Franco Pannuti ETS
Lead sponsor
University of Bologna
Collaborator