Probiotics for cancer patients undergoing chemotherapy
The Effect of Probiotics ATG-F4 in Cancer Patients
This study is testing if a specific probiotic can help cancer patients with advanced colorectal or pancreatic cancer who are getting chemotherapy feel better and prevent weight loss.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Chungnam National University Hospital Academic / other |
| Drugs / interventions | chemotherapy, Cyclophosphamide |
| Locations | 1 site (Daejeon) |
| Trial ID | NCT06436976 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of probiotics, specifically Lactobacillus reuteri ATG-F4, on patients with advanced colorectal or pancreatic cancer who are receiving oxaliplatin-based chemotherapy. Participants will consume the probiotics while completing safety and side effect-related questionnaires, and providing blood and fecal samples over a 12-week period. The study aims to address chemotherapy-induced cachexia, which can lead to significant weight loss and muscle wasting, by exploring the potential benefits of probiotics in this context.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with advanced colorectal or pancreatic cancer undergoing oxaliplatin-based chemotherapy.
Not a fit: Patients with known brain metastases, malignant bowel obstruction, or other serious health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could help mitigate the adverse effects of chemotherapy, particularly cachexia, improving the quality of life for cancer patients.
How similar studies have performed: While the use of probiotics in cancer care is an emerging field, previous studies have shown promising results in managing side effects of chemotherapy, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients diagnosed with advanced colorectal cancer or pancreatic cancer who are undergoing treatment with Oxaliplatin-based chemotherapy at Chungnam National University Hospital, including both newly diagnosed and recurrent cases. * Aged 19 years or older. * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2 points. * Expected life expectancy of at least 3 months. * Ability to understand the requirements of the clinical trial and willingness to sign the informed consent form. Exclusion Criteria: * Presence of known brain metastases. * Malignant bowel obstruction requiring surgical intervention. * Uncontrolled, active infections, symptomatic congestive heart failure, unstable angina, cardiac arrhythmias, or any psychiatric/social conditions that may limit compliance with the study requirements. * Partial or complete intestinal obstruction. * Pregnant or lactating women. * Use of antibiotics, antifungals, or antiviral agents on more than one occasion within the past month. * Consumption of probiotics products or fermented milk more than twice within the past month. * Patients with neurological or psychiatric disorders.
Where this trial is running
Daejeon
- Chungnam National University Hospital — Daejeon, South Korea (Recruiting)
Study contacts
- Principal investigator: Hyewon Ryu, Professor — Department of Hematology Oncology
- Study coordinator: Hyewon Ryu, Professor
- Email: ryhw001@naver.com
- Phone: 82 + 42 280 6834
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.