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

Inclusion Criteria6

Patients pathologically diagnosed with non-metastatic head and neck malignant tumors;
Aged 18-80 years;
Eastern Cooperative Oncology Group performance status of ≤2;
Planning to receive definitive RT or postoperative adjuvant RT;
Normal liver, kidney and bone marrow function;
Sign informed consent.

Exclusion Criteria6

Known hypersensitivity or more severe allergies to Lactobacillus Reuteri components;
Those with poor compliance;
Pregnancy or breastfeeding;
History of head and neck radiotherapy;
Taking antifungal or viral medications one week prior to the start of radiation therapy.
Other patients (with any other serious other medical condition) who, in the opinion of the investigator, are not suitable for participation in this study.

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.