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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Probiotic Mixture
Dietary supplementParticipants 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
Other interventionParticipants 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.
Treatment groups
140 Participants
are divided into 2 treatment groupsGroup A: Probiotic MixtureExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
Gut Microbiota Alpha Diversity Indices
Alpha diversity assessed by Shannon, Simpson, and Chao indices derived from 16S ribosomal RNA sequencing.
Time frame
Baseline, 6 weeks, and 12 weeks2
Gut Microbiota Beta Diversity Metrics
Beta diversity assessed using Bray-Curtis and UniFrac dissimilarity metrics.
Time frame
Baseline, 6 weeks, and 12 weeks3
Relative Abundance of major Gut Microbiota Taxa
Relative abundance of major microbial taxa assessed by 16S ribosomal RNA sequencing and shotgun metagenomics.
Time frame
Baseline, 6 weeks, and 12 weeks4
Cachexia Status
Cachexia stage classified as no cachexia, precachexia, cachexia, or refractory cachexia.
Time frame
Baseline, 6 weeks, and 12 weeksSecondary outcomes
1
Symptom Distress Score
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.
Time frame
Baseline, 6 weeks, and 12 weeks2
Health-Related Quality of Life Assessed by the EuroQol 5-Dimension Questionnaire
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.
Time frame
Baseline, 6 weeks, and 12 weeks3
Intestinal Permeability Biomarkers
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.
Time frame
Baseline, 6 weeks, and 12 weeks4
Systemic Inflammation Cytokine
Systemic inflammation assessed by serum cytokine levels, including interleukin-1 (IL-1), interleukin-6 (IL-6), and interleukin-8 (IL-8).
Time frame
Baseline, 6 weeks, and 12 weeksLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fondazione ANT Franco Pannuti ETS
Lead sponsor
University of Bologna
Collaborator
Source ClinicalTrials.gov
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