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

Recruiting now · Not applicable

Conditions studied: Colo-rectal Cancer

In brief

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.

Key facts

Study ID: NCT06576986
Run by: Federal University of Minas Gerais
People needed: 80
Starts: 2023-12-12
Expected to finish: 2026-12-12
Last updated by the study team: 2024-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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)

You may not qualify if…

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 it is running

Escola de Enfermagem - UFMG — Belo Horizonte, Minas Gerais, Brazil (enrolling)

Full record on ClinicalTrials.gov

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