NCT06576986 Effect of Synbiotic Supplementation on the Prevention of Mucositis in Cancer Patients Undergoing Chemotherapy
| NCT ID | NCT06576986 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Federal University of Minas Gerais |
| Condition | Colo-rectal Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2023-12-12 |
| Primary Completion | 2025-12-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 80 participants in total. It began in 2023-12-12 with a primary completion date of 2025-12-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Introduction: In the 2023-2025 period, colorectal cancer (CRC) will be the third most common type of cancer in Brazil. The most commonly used therapeutic approaches are chemotherapy (QTx) and radiotherapy (RTx). QTx agents, such as capecitabine, affect both malignant cells and normal cells such as gastrointestinal, capillary and immune cells. Cellular damage in the gastrointestinal tract (GIT) results in various symptoms, such as mucositis and diarrhea. Diarrhea is linked to mucosal damage and can result in dehydration, malnutrition and hospitalization, leading to cardiovascular complications and death. Mucositis is inflammation that affects the GIT. This condition makes treatment difficult, leading to reductions, delays or interruption of QTx. These scenarios harm the patient's prognosis and quality of life, resulting in high costs for symptom control, nutritional assistance, management of secondary infections and hospitalization. The Mucositis Study Group (MASCC/ISOO) guidelines recommend the use of probiotics as a preventive measure against diarrhea in cancer patients undergoing QTx and/or RTx. However, the safety of using probiotics in immunosuppressed patients is still controversial and hypotheses are based on epidemiological and experimental studies. This makes it necessary to evaluate whether supplementation with pro- or synbiotics before chemotherapy would have the same beneficial results. Objective: To evaluate the effect of synbiotic supplementation on the prevention, incidence and severity of mucositis in cancer patients undergoing QTx. Method: This is a single-center parallel double-masked randomized clinical trial to be carried out at the Borges da Costa/UFMG Outpatient Clinic at Hospital das Clínicas in Belo Horizonte - Minas Gerais (HC-BH/MG). The inclusion criteria are patients diagnosed with CRC eligible for first-line treatment with Capecitabine, aged ≥ 18 years, both sexes, signed the informed consent form. The study was approved by CEP-UFMG. Expected results: It is expected that supplementation with synbiotics in the pre-QTx period will promote modulation of the microbiota and strengthening of the intestinal barrier, resulting in a lower incidence and severity of mucositis and diarrhea, improving the quality of life of these patients.
Eligibility 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.
Contact & Investigator
Simone de Vasconcelos Generoso
PRINCIPAL INVESTIGATOR
Escola de Enfermagem - UFMG
Frequently Asked Questions
Who can join the NCT06576986 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Colo-rectal Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06576986 currently recruiting?
Yes, NCT06576986 is actively recruiting participants. Contact the research team at simonenutufmg@gmail.com for enrollment information.
Where is the NCT06576986 trial being conducted?
This trial is being conducted at Belo Horizonte, Brazil.
Who is sponsoring the NCT06576986 clinical trial?
NCT06576986 is sponsored by Federal University of Minas Gerais. The principal investigator is Simone de Vasconcelos Generoso at Escola de Enfermagem - UFMG. The trial plans to enroll 80 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.