Clinical trial · Interventional
Cachexia and Gut Microbiota in Patients With Breast Cancer Receiving Home Care
Evaluation of Cancer Cachexia and Analysis of Gut Microbiota in Patients With Breast Cancer Receiving Home Care
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer Cachexia | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Other | — | UNRESOLVED |
| Probiotic Mixture | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Probiotic Mixture
- description
- 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.
- interventionNames
- Dietary Supplement: Probiotic Mixture
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Other: Placebo
Primary outcomes (4)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (28)
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- BACKGROUNDStudenski SA, Peters KW, Alley DE, Cawthon PM, McLean RR, Harris TB, Ferrucci L, Guralnik JM, Fragala MS, Kenny AM, Kiel DP, Kritchevsky SB, Shardell MD, Dam TT, Vassileva MT. The FNIH sarcopenia project: rationale, study description, conference recommendations, and final estimates. J Gerontol A Biol Sci Med Sci. 2014 May;69(5):547-58. doi: 10.1093/gerona/glu010. PMID 24737557
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- BACKGROUNDHarris JA, Benedict FG. A Biometric Study of Human Basal Metabolism. Proc Natl Acad Sci U S A. 1918 Dec;4(12):370-3. doi: 10.1073/pnas.4.12.370. No abstract available. PMID 16576330
- BACKGROUNDHui D, Bruera E. The Edmonton Symptom Assessment System 25 Years Later: Past, Present, and Future Developments. J Pain Symptom Manage. 2017 Mar;53(3):630-643. doi: 10.1016/j.jpainsymman.2016.10.370. Epub 2016 Dec 29. PMID 28042071
- BACKGROUNDBruera E, Kuehn N, Miller MJ, Selmser P, Macmillan K. The Edmonton Symptom Assessment System (ESAS): a simple method for the assessment of palliative care patients. J Palliat Care. 1991 Summer;7(2):6-9.