Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Brazil / NCT06576986
Recruiting Not applicable

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

NCT06576986 · tracked via the Priya Life Science Brazil tracker
Sponsor
Federal University of Minas Gerais
Phase
Not applicable
Started
2023-12-12
Last updated
2024-08-29

Condition(s) studied

Colo-rectal Cancer

Investigational drug(s) / intervention(s)

SymbioticMaltodextrin

Symbiotic: 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.

Maltodextrin: 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.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Escola de Enfermagem - UFMG Belo Horizonte Minas Gerais Recruiting

More Federal University of Minas Gerais trials in Brazil

Effect of Training and Use of Cane on Gait in Individuals With Parkinson's Disease Recruiting
Impact of HMB Supplementation on Inflammation and Outcomes in Head and Neck Cancer Recruiting
Clinical Evaluation of a Hyperbolic Paraboloid Triple-Abutment on Morse Taper Dental Implants Enrolling by invitation
Chronic Effect of Fasting Recruiting
Telehealth Intervention Involving HEARTS Technical Package and Activity Monitor to Promote Physical Activity Post-stroke Recruiting

Other trials for the same condition

Development of Polygenic Risk Scores in Colon Cancer Patients Through the Study of Ancestry and Diversity in Genetic Maps of the Brazilian Population - ORIGEM Project Enrolling by invitation
Phase 2 Trial of Voyager V1 in Combination With Cemiplimab in Cancer Patients Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06576986 on ClinicalTrials.gov ↗ ← All trials in Brazil