Effect of Synbiotic Supplementation on the Prevention of Mucositis in Cancer Patients Undergoing Chemotherapy
NCT Number: NCT06576986
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Colo-rectal Cancer
Interventions: DIETARY_SUPPLEMENT: Symbiotic|DIETARY_SUPPLEMENT: Maltodextrin
Sponsor: Federal University of Minas Gerais
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 80
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2023-12-12
Completion Date: 2026-12-12
Locations: Escola de Enfermagem - UFMG, Belo Horizonte, MG, 30130-100, Brazil

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.

Primary Outcome Measures: Intestinal Microbiota, Fecal calprotectin measured by ELISA., six months after collecting data from all research participants|Intestinal Microbiota, production of short-chain fatty acids., six months after collecting data from all research participants|Intestinal Microbiota, analysis of intestinal microbiota composition by sequencing the 16S rRNA gene., six months after collecting data from all research participants|Clinical Nutritional Diagnostic, Body mass index BMI in kg/m², six months after collecting data from all research participants|Nutritional Diagnostic, body weight in kg, six months after collecting data from all research participants|Nutritional Diagnostic, height in m, six months after collecting data from all research participants|Nutritional Diagnostic, circumferences in cm, six months after collecting data from all research participants|Nutritional Diagnostic, body composition via triceps skin fold thickness in mm, six months after collecting data from all research participants|Nutritional Diagnostic, hand grip resistance assessed by dynamometry in kg, six months after collecting data from all research participants|Nutritional Diagnostic, Food Frequency Questionnaire, six months after collecting data from all research participants|Nutritional Diagnostic, 24-hour recall, six months after collecting data from all research participants|Effect of the synbiotic in pain, Visual Analogue Score for Pain using the Visual Analogue Scale, six months after collecting data from all research participants|inflammatory marker, Blood samples for Tumor Necrosis Factor TNF in pg/mL, six months after collecting data from all research participants|inflammatory marker, Fatty Acid Binding Protein FABP2 in ng/mL, six months after collecting data from all research participants|inflammatory marker, Lipopolysaccharide Binding Protein LBP in µg/mL, six months after collecting data from all research participants|inflammatory marker, Lipopolysaccharide LPS in µg/mL, six months after collecting data from all research participants|inflammatory marker, leukogram White Blood Cell Count in cells/µL, six months after collecting data from all research participants|Questionnaire to assess quality of life, EORTC QLQ-C30 for all cancer patients, six months after collecting data from all research participants|Questionnaire to assess quality of life, EORTC QLQ-CR29 for colorectal cancer patients, six months after collecting data from all research participants