Investigating how gut bacteria affect diarrhea from cancer treatment
Role of the Gut Microbiome in Anti-tumor Therapy Induced Diarrhea
This study is trying to see how the bacteria in the gut affect diarrhea in patients with liver cancer who are being treated with specific cancer drugs.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Medical University of Graz Academic / other |
| Drugs / interventions | lenvatinib |
| Locations | 1 site (Graz) |
| Trial ID | NCT05873231 on ClinicalTrials.gov |
What this trial studies
This observational study examines the role of the gut microbiome in the development of diarrhea as a side effect of anti-cancer therapies, specifically focusing on patients with hepatocellular carcinoma (HCC) undergoing treatment with tyrosine kinase inhibitors (TKIs). By assessing the gut microbiome composition in patients starting systemic anti-cancer therapy, the study aims to identify potential mechanisms behind TKI-induced diarrhea. The research will involve a longitudinal cohort of patients, tracking their microbiome changes and correlating them with the incidence of diarrhea during treatment. This could lead to a better understanding of how to manage side effects and improve treatment efficacy.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who are starting systemic anti-cancer therapy for hepatocellular carcinoma.
Not a fit: Patients with pre-existing diarrhea or those who have received antibiotics or probiotics shortly before the study may not benefit from this research.
Why it matters
Potential benefit: If successful, this study could lead to improved management of diarrhea in cancer patients, enhancing their treatment experience and outcomes.
How similar studies have performed: While there is emerging data on the impact of the gut microbiome on cancer treatment side effects, this specific approach is relatively novel and has not been extensively tested in larger cohorts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 18 years or older * Start of a systemic anti-cancer therapy * Informed consent Exclusion Criteria: * • Pre-existing diarrhoea * Antibiotic therapy -4 to -1 week before inclusion * Probiotic treatment -4 to -1 week before inclusion * Inability to give informed consent
Where this trial is running
Graz
- Department of Internal Medicine, Medical University of Graz — Graz, Austria (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.