Using synbiotics to prevent mucositis in colorectal cancer patients undergoing chemotherapy
Effect of Synbiotic Supplementation on the Prevention of Mucositis in Cancer Patients Undergoing Chemotherapy: Randomized, Double-masked, Parallel, Single-center Clinical Trial
This study is testing if taking synbiotics can help prevent mouth sores and diarrhea in people with colorectal cancer who are starting chemotherapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Federal University of Minas Gerais Academic / other |
| Drugs / interventions | Chemotherapy |
| Locations | 1 site (Belo Horizonte, Minas Gerais) |
| Trial ID | NCT06576986 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effect of synbiotic supplementation on preventing mucositis and diarrhea in patients with colorectal cancer receiving chemotherapy. It aims to determine whether administering synbiotics before chemotherapy can mitigate gastrointestinal damage caused by treatment, which often leads to severe complications. The study will include patients who are newly diagnosed with colorectal cancer and are eligible for chemotherapy with capecitabine. Participants will be monitored for symptoms of mucositis and diarrhea throughout their treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old with a colorectal tumor in their first oncological treatment, eligible for capecitabine chemotherapy, and residing in Belo Horizonte or its metropolitan area.
Not a fit: Patients with certain gastrointestinal conditions, such as inflammatory bowel diseases or those who have had recent antibiotic use, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the quality of life and treatment outcomes for colorectal cancer patients undergoing chemotherapy.
How similar studies have performed: Previous studies have suggested that probiotics may help prevent diarrhea in cancer patients, but the safety and efficacy of synbiotics in this context remain to be fully established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Colorectal tumor in the first oncological treatment * Age over 18 years old * Both sexes * Eligible for protocol with capecitabine alone or associated with oxaliplatin * Patients WITHOUT colostomy or WITH colostomy in the transverse/descending/sigmoid region * Patient undergoing Radiotherapy treatment associated with Chemotherapy * Patients residing in Belo Horizonte and the metropolitan region * Patients who Accept and sign the Informed Consent Form (TCLE) Exclusion Criteria: * Diagnosis of gastrointestinal carcinoid and stromal tumor (GIST) * Patients with Ileostomy * Patients with colostomy in the ascending region of the colon * Inflammatory bowel diseases: Crohn's and Colitis * Use of antibiotics and antifungals in the last 15 days * Use of prebiotic/probiotic and/or synbiotic in the last 15 days * Use of antidiarrheal medication in the last 15 days * Presence of fever and mucus discharge * Pregnant or breastfeeding women * Patients who refuse to participate in the study.
Where this trial is running
Belo Horizonte, Minas Gerais
- Escola de Enfermagem - UFMG — Belo Horizonte, Minas Gerais, Brazil (Recruiting)
Study contacts
- Principal investigator: Simone de Vasconcelos Generoso — Escola de Enfermagem - UFMG
- Study coordinator: Simone de Vasconcelos Generoso
- Email: simonenutufmg@gmail.com
- Phone: 988128650
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.