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

June 16, 2026 updated by: Fondazione ANT Franco Pannuti ETS

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cancer cachexia is a multifactorial syndrome defined by an ongoing loss of skeletal muscle mass that cannot be fully reversed by conventional nutritional support and leads to a progressive functional impairment. Moreover, cachexia is characterized by involuntary weight loss, reduced food intake, systemic inflammation, and metabolic alteration. Its pathophysiology is characterized by a negative protein and energy balance driven by a variable combination of reduced food intake and abnormal metabolism. It is common in people with advanced cancer and is associated with lower quality of life, poorer functional status, and shorter survival. Cachexia syndrome can develop progressively through various stages - precachexia, cachexia, and refractory cachexia and its severity can be classified according to degree of depletion of energy stores and body protein in combination with degree of ongoing weight loss. Refractory cachexia, which is considered no longer reversible, represents a very advanced stage associated with progressive worsening of quality of life and severe hypercatabolism, with an expected survival of less than three months.

The Gut Microbiota (GM) is increasingly recognized as a possible factor involved in the development and progression of cancer cachexia. Alterations in the GM, often referred to as dysbiosis, may contribute to systemic inflammation, intestinal barrier dysfunction, altered nutrient metabolism, and loss of muscle mass. Previous studies have shown that people with cancer cachexia may have specific alterations in GM, including differences in the abundance of certain bacterial groups and lower production of anti-inflammatory metabolites such as short-chain fatty acids.

The association between alterations in the GM and the development of cancer cachexia suggests that modifying the GM to correct cachexia-related dysbiosis may lead to new integrative approaches for the management of this highly burdensome condition.

Recent studies suggest that Breast Cancer (BC) is associated with GM dysbiosis and that changes in GM composition and function may play a crucial role in tumor development and progression. In these studies, patients with BC frequently show a different GM composition compared with healthy individuals, including specific alterations in certain bacterial taxa and a reduction in microbial alpha diversity. However, limited data are available on the relationship between GM and cachexia in people with BC, especially among those receiving home-based supportive and palliative care.

Considering that BC is one of the most common cancers among women assisted by the home supportive and palliative care program, it is particularly important to identify strategies that may improve the quality of life of these patients. A simple and feasible option to support the nutritional and functional status of these particularly vulnerable patients could be probiotic supplementation. At present, to our knowledge, no studies have evaluated the effect of probiotic supplementation on cachexia status in patients with BC.

This study was developed to better understand the role of the GM in the nutritional and functional condition of people with BC receiving home care and to explore whether modulation of the GM through a probiotic mixture may be associated with changes in cachexia-related measures.

The primary objective of the study is to evaluate whether GM composition, diversity, and function are associated with the stage of cachexia in people with BC receiving home care.

Secondary objectives include:

  • Evaluate changes in GM composition, diversity, and function after 12 weeks in participants who received either a probiotic mixture or placebo.
  • Evaluate the association between changes in GM composition and function and changes in cachexia status after 12 weeks in participants who received either a probiotic mixture or placebo.
  • Evaluate inflammatory biomarkers and intestinal permeability biomarkers at baseline and after 12 weeks in relation to cachexia status in participants who received either a probiotic mixture or placebo.

All study procedures will be performed during home visits as part of the participants' regular home care program.

The study consists of two consecutive phases: an observational phase and an interventional phase.

I) Observational phase During the observational phase, all eligible participants (expected number: 200 patients) entering the home care program will undergo a baseline assessment. This phase is designed to evaluate the association between GM composition, diversity, and function and the stage of cachexia at baseline.

Participants will be classified into one of the following cachexia stages:

  • No cachexia
  • Precachexia
  • Cachexia
  • Refractory cachexia Cachexia stage will be defined using body weight loss, Body Mass Index, body composition, sarcopenia, oral intake, systemic inflammation, and Karnofsky Performance Status.

The observational phase aims to determine whether specific GM profiles are associated with different stages of cachexia at the entry and whether these profiles are related to inflammatory markers, intestinal permeability, symptoms, and quality of life.

Participants who do not have refractory cachexia and who have a life expectancy greater than six weeks will be eligible for the interventional phase.

II) Interventional phase The interventional phase is a randomized, double-blind, placebo-controlled study with two parallel groups. Approximately 140 participants are expected to enter the randomized interventional phase, with about 70 participants in each study group.

Participants will be randomly assigned in a 1:1 ratio to one of the following groups:

  • Experimental group
  • Control group Participants in the experimental group will take a probiotic mixture containing different strains of lactic acid bacteria and bifidobacteria orally twice daily for twelve weeks. Participants in the control group will receive a placebo in identical sachets for the same duration.

Neither the participants nor the study team performing the assessments will know the assigned intervention arm. Randomization will be centrally managed and stratified according to age and Karnofsky Performance Status to ensure balance between the groups.

Participants will undergo study assessments at three time points:

  • Baseline
  • Six weeks
  • Twelve weeks At each assessment, clinical information, biological samples, and questionnaire data will be collected.

Clinical data collected during the study will include:

  • Tumor stage and metastatic disease
  • Previous and ongoing cancer treatments
  • Pain treatment and other medications
  • Karnofsky Performance Status
  • Nutritional status
  • Weight loss during the previous six months
  • Body Mass Index
  • Dietary intake
  • Body composition and sarcopenia assessment
  • Perceived symptom burden
  • Quality of life Body composition and sarcopenia will be evaluated using bioimpedance analysis and handgrip strength measurement.

Participants will also complete questionnaires on symptoms and quality of life, including:

  • Edmonton Symptom Assessment Scale
  • EuroQol 5-Dimension questionnaire (EQ-5D) Blood, stool, and urine samples will be collected at baseline, six weeks, and twelve weeks.

Blood samples will be used to measure:

  • Inflammatory markers
  • Cytokines
  • Markers of intestinal permeability

Stool samples will be used to evaluate:

  • GM composition
  • GM diversity
  • Fecal calprotectin
  • Functional and metabolomic profiles of the GM Urine samples will be collected for metabolomic analyses.

GM analysis will include:

  • 16S Ribosomal RNA (16S rRNA) sequencing
  • Shotgun metagenomic sequencing
  • Alpha diversity indices
  • Beta diversity analyses
  • Relative abundance of major microbial groups
  • Functional and metabolomic profiling The study will also evaluate biomarkers of systemic inflammation and intestinal permeability, including inflammatory cytokines, lipopolysaccharide-related markers, zonulin, intestinal fatty acid-binding protein, and other serum and fecal biomarkers.

Participants may continue to receive their prescribed oncologic treatments, including chemotherapy, radiotherapy, and hormonal therapy, provided that these treatments are documented and monitored during the trial.

Participants may also continue or start supportive treatments, including antiemetics, pain medications, and other drugs used to manage symptoms related to cancer. Participants who require antibiotic treatment or the initiation of total artificial nutrition during the 12-week trial period will discontinue the intervention phase of the study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
140

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Rita Ostan, Biological Sciences
  • Phone Number: +393487900191
  • Email: rita.ostan@ant.it

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Probiotic Mixture
Participants will receive an oral probiotic mixture twice daily for 12 weeks in addition to their usual oncologic treatment and supportive care. Assessments will be performed at baseline, 6 weeks, and 12 weeks during home visits.
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.
Placebo Comparator: Placebo
Participants 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. Assessments will be performed at baseline, 6 weeks, and 12 weeks during home visits.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gut Microbiota Alpha Diversity Indices
Time Frame: Baseline, 6 weeks, and 12 weeks
Alpha diversity assessed by Shannon, Simpson, and Chao indices derived from 16S ribosomal RNA sequencing.
Baseline, 6 weeks, and 12 weeks
Gut Microbiota Beta Diversity Metrics
Time Frame: Baseline, 6 weeks, and 12 weeks
Beta diversity assessed using Bray-Curtis and UniFrac dissimilarity metrics.
Baseline, 6 weeks, and 12 weeks
Relative Abundance of major Gut Microbiota Taxa
Time Frame: Baseline, 6 weeks, and 12 weeks
Relative abundance of major microbial taxa assessed by 16S ribosomal RNA sequencing and shotgun metagenomics.
Baseline, 6 weeks, and 12 weeks
Cachexia Status
Time Frame: Baseline, 6 weeks, and 12 weeks
Cachexia stage classified as no cachexia, precachexia, cachexia, or refractory cachexia.
Baseline, 6 weeks, and 12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptom Distress Score
Time Frame: Baseline, 6 weeks, and 12 weeks
Symptom burden measured by the Edmonton Symptom Assessment Scale, including pain, nausea, tiredness, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath. The Symptom Distress Score ranges from 0 to 90, with higher scores indicating greater symptom burden and worse clinical status.
Baseline, 6 weeks, and 12 weeks
Health-Related Quality of Life Assessed by the EuroQol 5-Dimension Questionnaire
Time Frame: Baseline, 6 weeks, and 12 weeks
Health-related quality of life assessed using the EuroQol 5-Dimension Questionnaire (EQ-5D). The EQ-5D evaluates five dimensions of health status (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Participants also rate their overall health using the EQ Visual Analogue Scale (EQ VAS), ranging from 0 to 100, where 0 indicates the worst imaginable health state and 100 indicates the best imaginable health state. Higher scores indicate better health-related quality of life.
Baseline, 6 weeks, and 12 weeks
Intestinal Permeability Biomarkers
Time Frame: Baseline, 6 weeks, and 12 weeks
Serum and fecal biomarkers of intestinal permeability, including Endotoxin Core Antibodies (EndoCab) immunoglobulin M (IgM), immunoglobulin A (IgA), and immunoglobulin G (IgG), soluble cluster of differentiation 14 (sCD14), lipopolysaccharide-binding protein (LBP), intestinal fatty acid-binding protein (I-FABP), zonulin, plasma vesicle-associated protein-1 (PV1), and fecal immunoglobulin A.
Baseline, 6 weeks, and 12 weeks
Systemic Inflammation Cytokine
Time Frame: Baseline, 6 weeks, and 12 weeks
Systemic inflammation assessed by serum cytokine levels, including interleukin-1 (IL-1), interleukin-6 (IL-6), and interleukin-8 (IL-8).
Baseline, 6 weeks, and 12 weeks
Fecal Calprotectin Concentration
Time Frame: Baseline, 6 weeks, and 12 weeks
Intestinal inflammation assessed by fecal calprotectin.
Baseline, 6 weeks, and 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione ANT Franco Pannuti ETS

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Bologna

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Enrico Ruggeri, Medicine, Fondazione ANT Franco Pannuti ETS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 10, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 578-2025-OSS-AUSLBO (Other Identifier: Ethics Committee approval number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared due to privacy and confidentiality considerations related to sensitive clinical and biological data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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