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

NCT07653698 | Not Yet Recruiting

• 1 other identifier: 578-2025-OSS-AUSLBO
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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

Breast Cancer; Cancer Cachexia

Keywords

Breast Cancer; Cancer cachexia; Gut Microbiota; Palliative Care; Probiotic Mixture; Dysbiosis

Outcome Measures

Primary Outcomes (4)

• Gut Microbiota Alpha Diversity Indices

  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

  Beta diversity assessed using Bray-Curtis and UniFrac dissimilarity metrics.

  Baseline, 6 weeks, and 12 weeks

• Relative Abundance of major Gut Microbiota Taxa

  Relative abundance of major microbial taxa assessed by 16S ribosomal RNA sequencing and shotgun metagenomics.

  Baseline, 6 weeks, and 12 weeks

• Cachexia Status

  Cachexia stage classified as no cachexia, precachexia, cachexia, or refractory cachexia.

  Baseline, 6 weeks, and 12 weeks

Secondary Outcomes (5)

• Symptom Distress Score

  Baseline, 6 weeks, and 12 weeks

• Health-Related Quality of Life Assessed by the EuroQol 5-Dimension Questionnaire

  Baseline, 6 weeks, and 12 weeks

• Intestinal Permeability Biomarkers

  Baseline, 6 weeks, and 12 weeks

• Systemic Inflammation Cytokine

  Baseline, 6 weeks, and 12 weeks

• Fecal Calprotectin Concentration

  Baseline, 6 weeks, and 12 weeks

Study Arms (2)

Probiotic Mixture

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Probiotic Mixture DIETARY_SUPPLEMENT

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.

Probiotic Mixture

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione ANT Franco Pannuti ETS: lead
• University of Bologna: collaborator

Related Publications (28)

• Dodds RM, Syddall HE, Cooper R, Benzeval M, Deary IJ, Dennison EM, Der G, Gale CR, Inskip HM, Jagger C, Kirkwood TB, Lawlor DA, Robinson SM, Starr JM, Steptoe A, Tilling K, Kuh D, Cooper C, Sayer AA. Grip strength across the life course: normative data from twelve British studies. PLoS One. 2014 Dec 4;9(12):e113637. doi: 10.1371/journal.pone.0113637. eCollection 2014.

  PMID: 25474696 BACKGROUND

• Studenski 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 BACKGROUND

• Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jul 1;48(4):601. doi: 10.1093/ageing/afz046. No abstract available.

  PMID: 31081853 BACKGROUND

• Harris 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 BACKGROUND

• Hui 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 BACKGROUND

• Bruera 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.

  PMID: 1714502 BACKGROUND

• Moro C, Brunelli C, Miccinesi G, Fallai M, Morino P, Piazza M, Labianca R, Ripamonti C. Edmonton symptom assessment scale: Italian validation in two palliative care settings. Support Care Cancer. 2006 Jan;14(1):30-7. doi: 10.1007/s00520-005-0834-3. Epub 2005 Jun 4.

  PMID: 15937688 BACKGROUND

• Crooks V, Waller S, Smith T, Hahn TJ. The use of the Karnofsky Performance Scale in determining outcomes and risk in geriatric outpatients. J Gerontol. 1991 Jul;46(4):M139-44. doi: 10.1093/geronj/46.4.m139.

  PMID: 2071835 BACKGROUND

• Balestroni G, Bertolotti G. [EuroQol-5D (EQ-5D): an instrument for measuring quality of life]. Monaldi Arch Chest Dis. 2012 Sep;78(3):155-9. doi: 10.4081/monaldi.2012.121. Italian.

  PMID: 23614330 BACKGROUND

• Schwenkglenks M, Matter-Walstra K. Is the EQ-5D suitable for use in oncology? An overview of the literature and recent developments. Expert Rev Pharmacoecon Outcomes Res. 2016;16(2):207-19. doi: 10.1586/14737167.2016.1146594. Epub 2016 Feb 18.

  PMID: 26808097 BACKGROUND

• Stone CA, Tiernan E, Dooley BA. Prospective validation of the palliative prognostic index in patients with cancer. J Pain Symptom Manage. 2008 Jun;35(6):617-22. doi: 10.1016/j.jpainsymman.2007.07.006. Epub 2008 Feb 8.

  PMID: 18261876 BACKGROUND

• Laborda-Illanes A, Sanchez-Alcoholado L, Dominguez-Recio ME, Jimenez-Rodriguez B, Lavado R, Comino-Mendez I, Alba E, Queipo-Ortuno MI. Breast and Gut Microbiota Action Mechanisms in Breast Cancer Pathogenesis and Treatment. Cancers (Basel). 2020 Aug 31;12(9):2465. doi: 10.3390/cancers12092465.

  PMID: 32878124 BACKGROUND

• Goedert JJ, Jones G, Hua X, Xu X, Yu G, Flores R, Falk RT, Gail MH, Shi J, Ravel J, Feigelson HS. Investigation of the association between the fecal microbiota and breast cancer in postmenopausal women: a population-based case-control pilot study. J Natl Cancer Inst. 2015 Jun 1;107(8):djv147. doi: 10.1093/jnci/djv147. Print 2015 Aug.

  PMID: 26032724 BACKGROUND

• Dewys WD, Begg C, Lavin PT, Band PR, Bennett JM, Bertino JR, Cohen MH, Douglass HO Jr, Engstrom PF, Ezdinli EZ, Horton J, Johnson GJ, Moertel CG, Oken MM, Perlia C, Rosenbaum C, Silverstein MN, Skeel RT, Sponzo RW, Tormey DC. Prognostic effect of weight loss prior to chemotherapy in cancer patients. Eastern Cooperative Oncology Group. Am J Med. 1980 Oct;69(4):491-7. doi: 10.1016/s0149-2918(05)80001-3.

  PMID: 7424938 BACKGROUND

• Bernstein R, Isdale J, Pinto M, Du Toit Zaaijman J, Jenkins T. Short rib-polydactyly syndrome: a single or heterogeneous entity? A re-evaluation prompted by four new cases. J Med Genet. 1985 Feb;22(1):46-53. doi: 10.1136/jmg.22.1.46.

  PMID: 3981580 BACKGROUND

• Varian BJ, Gourishetti S, Poutahidis T, Lakritz JR, Levkovich T, Kwok C, Teliousis K, Ibrahim YM, Mirabal S, Erdman SE. Beneficial bacteria inhibit cachexia. Oncotarget. 2016 Mar 15;7(11):11803-16. doi: 10.18632/oncotarget.7730.

  PMID: 26933816 BACKGROUND

• Ayling RM, Kok K. Fecal Calprotectin. Adv Clin Chem. 2018;87:161-190. doi: 10.1016/bs.acc.2018.07.005. Epub 2018 Oct 1.

  PMID: 30342711 BACKGROUND

• Hakozaki T, Nolin-Lapalme A, Kogawa M, Okuma Y, Nakamura S, Moreau-Amaru D, Tamura T, Hosomi Y, Takeyama H, Richard C, Hosokawa M, Routy B. Cancer Cachexia among Patients with Advanced Non-Small-Cell Lung Cancer on Immunotherapy: An Observational Study with Exploratory Gut Microbiota Analysis. Cancers (Basel). 2022 Nov 2;14(21):5405. doi: 10.3390/cancers14215405.

  PMID: 36358821 BACKGROUND

• Lauring AS, Lee TH, Martin JN, Hunt PW, Deeks SG, Busch M. Lack of evidence for mtDNA as a biomarker of innate immune activation in HIV infection. PLoS One. 2012;7(11):e50486. doi: 10.1371/journal.pone.0050486. Epub 2012 Nov 29.

  PMID: 23209754 BACKGROUND

• Ubachs J, Ziemons J, Soons Z, Aarnoutse R, van Dijk DPJ, Penders J, van Helvoort A, Smidt ML, Kruitwagen RFPM, Baade-Corpelijn L, Olde Damink SWM, Rensen SS. Gut microbiota and short-chain fatty acid alterations in cachectic cancer patients. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):2007-2021. doi: 10.1002/jcsm.12804. Epub 2021 Oct 5.

  PMID: 34609073 BACKGROUND

• Panebianco C, Villani A, Potenza A, Favaro E, Finocchiaro C, Perri F, Pazienza V. Targeting Gut Microbiota in Cancer Cachexia: Towards New Treatment Options. Int J Mol Sci. 2023 Jan 17;24(3):1849. doi: 10.3390/ijms24031849.

  PMID: 36768173 BACKGROUND

• Herremans KM, Riner AN, Cameron ME, Trevino JG. The Microbiota and Cancer Cachexia. Int J Mol Sci. 2019 Dec 12;20(24):6267. doi: 10.3390/ijms20246267.

  PMID: 31842339 BACKGROUND

• Hills RD Jr, Pontefract BA, Mishcon HR, Black CA, Sutton SC, Theberge CR. Gut Microbiome: Profound Implications for Diet and Disease. Nutrients. 2019 Jul 16;11(7):1613. doi: 10.3390/nu11071613.

  PMID: 31315227 BACKGROUND

• Araos R, D'Agata EMC. The human microbiota and infection prevention. Infect Control Hosp Epidemiol. 2019 May;40(5):585-589. doi: 10.1017/ice.2019.28. Epub 2019 Feb 19.

  PMID: 30777586 BACKGROUND

• Zaorsky NG, Churilla TM, Egleston BL, Fisher SG, Ridge JA, Horwitz EM, Meyer JE. Causes of death among cancer patients. Ann Oncol. 2017 Feb 1;28(2):400-407. doi: 10.1093/annonc/mdw604.

  PMID: 27831506 BACKGROUND

• Bruggeman AR, Kamal AH, LeBlanc TW, Ma JD, Baracos VE, Roeland EJ. Cancer Cachexia: Beyond Weight Loss. J Oncol Pract. 2016 Nov;12(11):1163-1171. doi: 10.1200/JOP.2016.016832.

  PMID: 27858548 BACKGROUND

• Nishikawa H, Goto M, Fukunishi S, Asai A, Nishiguchi S, Higuchi K. Cancer Cachexia: Its Mechanism and Clinical Significance. Int J Mol Sci. 2021 Aug 6;22(16):8491. doi: 10.3390/ijms22168491.

  PMID: 34445197 BACKGROUND

• Fearon K, Strasser F, Anker SD, Bosaeus I, Bruera E, Fainsinger RL, Jatoi A, Loprinzi C, MacDonald N, Mantovani G, Davis M, Muscaritoli M, Ottery F, Radbruch L, Ravasco P, Walsh D, Wilcock A, Kaasa S, Baracos VE. Definition and classification of cancer cachexia: an international consensus. Lancet Oncol. 2011 May;12(5):489-95. doi: 10.1016/S1470-2045(10)70218-7. Epub 2011 Feb 4.

  PMID: 21296615 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Dysbiosis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Enrico Ruggeri, Medicine

  Fondazione ANT Franco Pannuti ETS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rita Ostan, Biological Sciences

CONTACT

+393487900191; rita.ostan@ant.it

Enrico Ruggeri, Medicine

CONTACT

+393483102998; enrico.ruggeri@ant.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio to receive either a probiotic mixture or a placebo for 12 weeks. Randomization will be stratified according to age and Karnofsky Performance Status. The study includes two parallel groups and all assessments will be performed at baseline, 6 weeks, and 12 weeks during home visits.

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 17, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): August 31, 2028
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share