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

NCT07653698 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 140

Last updated 2026-06-17

No results posted yet for this study

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.

Conditions

Interventions

DIETARY_SUPPLEMENT

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.

OTHER

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.

Sponsors & Collaborators

  • University of Bologna

    collaborator OTHER

  • Fondazione ANT Franco Pannuti ETS

    lead OTHER

Principal Investigators

  • Enrico Ruggeri, Medicine · Fondazione ANT Franco Pannuti ETS

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-05-31
Completion
2028-08-31

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07653698 on ClinicalTrials.gov