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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Placebo-containing tablets |
|
| Experimental group | Experimental | Lactobacillus reuteri tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lactobacillus reuteri Tablets | Drug | Lactobacillus reuteri lozenges (NOW Foods, Sweden) contained 2×10^8 CFU viable cells of Lactobacillus reuteri as the active ingredient. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life as sssessed by the EORTC QLQ-C30 and QLQ-H&N35 Questionnaires | European Organization for Research and Treatment of Cancer (EORTC) Quality-of-life Questionnaire Core 30 (EORTC QLQ-C30) and Head and Neck Cancer Module (EORTC QLQ-H&N35). | 1 week before radiotherapy ; at the middle of radiotherapy (usually 3 weeks after the start of radiotherapy) ; at the end of radiotherapy(the last radiation dose received, usually 6 or 6.5 weeks) ; and 1, 2, 3 months after the end of radiotherapy. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xingchen Peng | West China Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital, Sichuan University | Chengdu | Sichuan | 610041 | China |
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| Placebo-containing tablets | Drug | 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. |
|
| Radiotherapy | Radiation | 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. |
|
The first determination of SOM to the first instance of non-severe OM (WHO grade <3), without a subsequent instance of SOM. |
| 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. | 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 any-grade oral mucositis (OM) | Time from the first day of radiotherapy to the first determination of OM. | 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. | From the start of radiotherapy to 8 weeks after completion of radiotherapy.The evaluation period is approximately 14 weeks and 14.5 weeks. |
| Mouth and throat soreness score | Patients report two scores via the Oral Mucositis Weekly Questionnaire (OMWQ): (1) the severity of mouth and throat soreness (MTS) and (2) the degree of its impact on oral activities (including swallowing, drinking, eating, talking, and sleeping). Both items use a Likert scale from 1 to 5, with higher scores indicating more severe symptoms or greater functional impairment. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| Hyposalivation | Hyposalivation was graded per CTCAE v5.0 (Grade 1-4), with higher grades indicating worse symptoms. | 1 week before radiotherapy ; at the middle of radiotherapy (usually 3 weeks after the start of radiotherapy) ; at the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks); and 1, 3 months after the end of radiotherapy. |
| Gustatory function | Taste strips test. | 1 week before radiotherapy ; at the middle of radiotherapy (usually 3 weeks after the start of radiotherapy) ; at the end of radiotherapy（the last radiation dose received, usually 6 or 6.5 weeks） ; and 1, 3 months after the end of radiotherapy. |
| Change in weight | The change in patient's body weight measured at baseline (pre-radiotherapy) and at the end of radiotherapy. | The time period is the period from the start of radiotherapy to the completion of radiotherapy. The evaluation period is approximately 6 weeks and 6.5 weeks. |
| The number of patients receiving parenteral nutrition | This outcome records the number of patients who receive parenteral nutrition from the start to the completion of radiotherapy. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| The number of patients receiving analgesics | This outcome records the number of patients who receive analgesics from the start to the completion of radiotherapy. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| Radiotherapy interruption rate | The number of patients who missed five or more consecutive radiations and the reasons for this are recorded during radiotherapy. | The time period is the period from the start of radiotherapy to the completion of radiotherapy.The evaluation period is approximately 6 weeks and 6.5 weeks. |
| Adverse events | Common Terminology Criteria for Adverse Events (CTCAE) 5.0 version | From the first day of radiotherapy to the day of the last radiation dose received, usually 6 or 6.5 weeks. |
| The composition and dynamics of salivary microbiota | Unstimulated whole saliva samples will be collected via spitting method at three time points: baseline, mid-term radiotherapy (the week corresponding to 50% completion of the planned radiation fractions), and the end of radiotherapy (the final week of RT). 16S rRNA gene sequencing will be performed to assess alterations in the oral microbiota. | 1 week before radiotherapy, the middle of radiotherapy (usually 3 weeks after the start of radiotherapy), and the end of radiotherapy (the last radiation dose received, usually 6 or 6.5 weeks). |
| ID | Term |
|---|---|
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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