RecruitingNot ApplicableNCT06390176

Lactobacillus Rhamnosus GG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy

Lactobacillus Rhamnosus LGG Alleviates Oral Mucositis in Patients Undergoing Radiotherapy for Malignant Head and Neck Tumors: A Randomized Controlled Trial

Sponsor

West China Hospital

Enrollment

132 participants

Start Date

Nov 10, 2023

Study Type

INTERVENTIONAL

Conditions

Oral Mucositis

Summary

Radiation therapy is a common treatment modality in the management of head and neck malignancies. However, head and neck tumors often have some adverse reactions when receiving radiation therapy, such as dry mouth, change of taste, oral mucositis, etc. Among them, the incidence of oral mucositis is more than 90%, and the incidence of oral mucositis of degree 3 or more than degree 3 is more than 50%. Severe oral mucositis seriously affects the quality of survival of patients. Lactobacillus rhamnosus GG (LGG) is a type of lactic acid bacterium, which is an important component of the microbiota in many parts of the human body. Lactobacillus rhamnosus GG (LGG) is a lactic acid bacterium found in the human body, extensively researched for its probiotic properties. It has been tested in clinical trials for preventing and treating oral mucosal reactions during intensified radiotherapy for head and neck squamous cell carcinoma. LGG adheres well to epithelial layers, produces a protective biofilm, and modulates immune responses. It shows promise in reducing radiation-induced oral mucositis and can be safely used in infant formula. Additionally, a daily dosage of 3×10\^9 CFU of LGG has been effective in treating irritable bowel syndrome without adverse effects

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether taking a probiotic called Lactobacillus Rhamnosus GG can reduce mouth sores (oral mucositis) in people with head and neck cancer who are undergoing radiation therapy. Mouth sores are a painful and common side effect of radiation in this area. **You may be eligible if...** - You are between 18 and 80 years old - You have been diagnosed with a head or neck cancer that has not spread to distant organs - You are scheduled to receive radiation therapy (as the main treatment or after surgery) - Your liver, kidney, and blood counts are within acceptable ranges **You may NOT be eligible if...** - You are allergic to the probiotic ingredients - You are pregnant or breastfeeding - You have had previous radiation to the head or neck - You are taking antifungal or antiviral medications within one week before starting radiation 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_SUPPLEMENTLactobacillus rhamnosus GG powder

Lactobacillus rhamnosus GG powder (PROBIOTICS Powder, USA) contained no less than 5×10\^8 CFU viable cells of Lactobacillus rhamnosus GG as the active ingredient.

DIETARY_SUPPLEMENTPlacebo-containing tablets

Starch preparations that look and taste like Lactobacillus rhamnosus GG powder

RADIATIONRadiotherapy

One of the inclusion criteria for the study was that patients with squamous carcinoma of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy, with radiotherapy using intensity-modulated radiotherapy techniques.