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Effect of Synbiotic Supplementation on the Prevention of Mucositis in Cancer Patients Undergoing Chemotherapy

RecruitingNAAges 18 Years - anyAllFederal University of Minas Gerais
NCT06576986 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Symbiotic
  • Maltodextrin
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Where

1 site
Escola de Enfermagem - UFMG
Belo Horizonte, Brazil
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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