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

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement, Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
China
West China Hospital, Sichuan University
RECRUITING
Chengdu
Contact Information
Primary
Xingchen Peng
pxx2014@163.com
+86 18980606753
Time Frame
Start Date: 2023-11-10
Estimated Completion Date: 2025-03-31
Participants
Target number of participants: 132
Treatments
Placebo_comparator: Control group
Placebo-containing tablets
Experimental: Experimental group
Lactobacillus rhamnosus GG (LGG)
Sponsors
Leads: West China Hospital

This content was sourced from clinicaltrials.gov