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

NCT06576986 | Recruiting DMC

• 1 other identifier: 30177920200005149
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Colo-rectal Cancer

Keywords

colorectal cancer; symbiotic; Mucositis; diarrhea; chemotherapy

Outcome Measures

Primary Outcomes (19)

• 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

Study Arms (4)

Capecitabine alone control

PLACEBO COMPARATOR

n the Control Group, patients received Maltodextrin as supplementation

Dietary Supplement: Maltodextrin

Capecitabine alone synbiotic

EXPERIMENTAL

In the Intervention Group, patients received the symbiotic Simbioflora as supplementation.

Dietary Supplement: Symbiotic

Capecitabine associated with control Oxaliplatin

PLACEBO COMPARATOR

n the Control Group, patients received Maltodextrin as supplementation

Dietary Supplement: Maltodextrin

Capecitabine associated with synbiotic Oxaliplatin

EXPERIMENTAL

In the Intervention Group, patients received the symbiotic Simbioflora as supplementation.

Dietary Supplement: Symbiotic

Interventions

Symbiotic DIETARY_SUPPLEMENT

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.

Also known as: Simbioflora

Capecitabine alone synbiotic; Capecitabine associated with synbiotic Oxaliplatin

Maltodextrin DIETARY_SUPPLEMENT

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.

Capecitabine alone control; Capecitabine associated with control Oxaliplatin

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead

Study Sites (1)

Escola de Enfermagem - UFMG

Belo Horizonte, Minas Gerais, 30130-100, Brazil

RECRUITING

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms; Mucositis; Diarrhea

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Gastroenteritis; Mouth Diseases; Stomatognathic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Simone de Vasconcelos Generoso

  Escola de Enfermagem - UFMG

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Simone de Vasconcelos Generoso

CONTACT

988128650; simonenutufmg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 11, 2024
• First Posted: August 29, 2024
• Study Start: December 12, 2023
• Primary Completion: December 12, 2025
• Study Completion (Estimated): December 12, 2026
• Last Updated: August 29, 2024

Record last verified: 2024-08

Locations

BR (1)