RecruitingNot ApplicableNCT06576986

Effect of Synbiotic Supplementation on the Prevention of Mucositis in 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


Sponsor

Federal University of Minas Gerais

Enrollment

80 participants

Start Date

Dec 12, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking a synbiotic supplement (a combination of probiotics and prebiotics) can prevent or reduce mouth sores (mucositis) — a painful side effect of chemotherapy — in people with colorectal cancer undergoing treatment. **You may be eligible if...** - You have colorectal cancer and are starting your first chemotherapy treatment - You are 18 years or older - You are being treated with capecitabine alone or with oxaliplatin - You are also receiving radiation therapy alongside chemotherapy **You may NOT be eligible if...** - You have already received prior chemotherapy or radiation for colorectal cancer - You have inflammatory bowel disease - You are pregnant or breastfeeding - You are unable to consent to participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTSymbiotic

The synbiotic used will be Simbioflora® (commercial preparation containing 5.5g of FOS added with four species of probiotic, Lactobacillus paracasei LPC-31; Lactobacillus rhamnosus HN001; Lactobacillus acidophilus NCFM; Bifidobacterium lactis HN019, at a concentration of 109 UFC per strain) supplied by Farmoquímica S.A. Supplementation will be administered orally, twice a day, before lunch and dinner, for ten days before chemotherapy treatment. Patients will be guided by researchers on dilution (100 mL of filtered water) and the correct purchase of the modules. Consumption control will be carried out daily, via telephone contact.

DIETARY_SUPPLEMENTMaltodextrin

Maltodextrin, used as control, will be purchased from the company PRODIET® under the trade name Carboch®. Supplementation will be administered orally, twice a day, before lunch and dinner, for ten days before chemotherapy treatment. Patients will be guided by researchers on dilution (100 mL of filtered water) and the correct purchase of the modules. Consumption control will be carried out daily, via telephone contact.


Locations(1)

Escola de Enfermagem - UFMG

Belo Horizonte, Minas Gerais, Brazil

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NCT06576986


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