To evaluate the efficacy and safety of Lactobacillus reuteri for prevention and treatment of oral mucositis in patients undergoing radiotherapy for malignant head and neck tumors.
The goal of this clinical trial is to evaluate the efficacy and safety of Lactobacillus reuteri in reducing the incidence, duration, and severity of severe oral mucositis (SOM). The main questions it aims to answer are whether Lactobacillus reuteri can effectively prevent and treat radiation-induced oral mucositis and whether it will cause adverse events in patients undergoing radiotherapy. Participants will be instructed to suck a Lactobacillus reuteri or placebo lozenge twice daily from the beginning to the end of RT. After using the lozenges, the patients should avoid eating, drinking and conducting any oral hygiene activities for at least 1 hour. Researchers will compare Lactobacillus reuteri group and placebo group to see if oral probiotic are beneficial in preventing and treating oral mucositis in patients undergoing radiotherapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
160
Lactobacillus reuteri lozenges (NOW Foods, Sweden) contained 2×10\^8 CFU viable cells of Lactobacillus reuteri as the active ingredient.
The placebo lozenges shared the same formulation as the L. reuteri lozenges but without the probiotic, whose appearance, taste, and color were identical to those of the Lactobacillus reuteri lozenges.
One of the inclusion criteria for the study was that patients with malignant tumors of the head and neck (including nasopharyngeal carcinoma) needed to receive either radiotherapy alone or simultaneous radiotherapy and chemotherapy.
West China Hospital, Sichuan University
Chengdu, Sichuan, China
The incidence of severe oral mucositis (SOM) (WHO grade ≥3)
Oral mucositis is assessed by trained radiotherapists according to World Health Organization (WHO) oral toxicity Scale.The WHO Oral Toxicity Scale categorizes oral mucositis into grades 0-4, with the higher the grade the more severe the patient's oral mucositis. Grade 0 means that the oral mucosa is normal and the patient has no symptoms or signs; grade 1 means that the mucosa is erythematous with or without pain and does not interfere with eating; grade 2 means that the mucosa is erythematous and ulcerated, but still able to eat solid food; grade 3 means that the mucosa is severely ulcerated with extensive erythema and unable to eat solid food; and grade 4 means that the ulcers of the mucosa are fused together into a sheet, and their severity is so severe that it is not possible to eat.
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The time to onset of severe oral mucositis (SOM) (WHO grade ≥3)
Time from the first day of radiotherapy to the first determination of SOM.
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The duration of severe oral mucositis (WHO grade ≥3)
The first determination of SOM to the first instance of non-severe OM (WHO grade \<3), without a subsequent instance of SOM.
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The incidence of oral mucositis (OM)
Oral mucositis is assessed by trained physicians according to World Health Organization (WHO) oral toxicity Scale.
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
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The time to onset of any-grade oral mucositis (OM)
Time from the first day of radiotherapy to the first determination of OM.
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.
The duration of any-grade oral mucositis (OM)
The first determination of OM to the first instance of non-OM, without a subsequent instance of OM.
Time frame: From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks.