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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorFondazione ANT Franco Pannuti ETS

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

140 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Fondazione ANT Franco Pannuti ETS

Lead sponsor

University of Bologna

Collaborator