Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis

Study Overview
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Brief Summary
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The goal of this study is to compare glutamine combined with thalidomide with glutamine alone in preventing radiation-induced oral mucositis. The aim of this study is to answer whether glutamine plus thalidomide could improve the median incidence time of grade 2 oral mucositis. Participants would be randomly divided into the two groups above mentioned.

Detailed Description
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Explore the therapeutic efficacy of Glutamine combined with Thalidomide as compared to Glutamine alone in preventing radiation-induced oral mucositis. The primary research endpoint is the median time to the onset of Grade II oral mucositis, defined as the number of days from the start of radiation therapy to the occurrence of Grade II oral mucositis.

Official Title
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Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis in Patients Undergoing radiotherapy-a Multicenter, Open-label, Randomized Controlled Study

Conditions
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Mucositis Oral

Intervention / Treatment
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* Drug: glutamine combined with thalidomide
* Drug: glutamine alone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 75 years old; Patients with postoperative oral malignant tumors confirmed by pathological histology or cytology and requiring radiotherapy; Patients who have received more than 45Gy of radiation in the oral area; ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-1; Basic hematological indicators are normal: White blood cell count ≥ 4×10^9/L; Absolute neutrophil count ≥ 1.5×10^9/L; Platelets ≥ 100×10^9/L; Hemoglobin ≥ 90 g/L; Basic renal function is normal: Serum creatinine ≤ 1.5×ULN (Upper Limit of Normal) or Creatinine Clearance Rate (CrCl) > 60 mL/min (using the Cockcroft-Gault formula): For women: CrCl = (140 - age) × weight (kg) × 0.85 / (72 × Scr mg/dl) For men: CrCl = (140 - age) × weight (kg) × 1.00 / (72 × Scr mg/dl) Basic liver function is normal: Serum total bilirubin ≤ 1.5×ULN; AST (Aspartate Aminotransferase) ≤ 2.5×ULN; ALT (Alanine Aminotransferase) ≤ 2.5×ULN. Signed written informed consent. Exclusion Criteria: Participated in another interventional clinical trial within the last 30 days; Patients with severe underlying oral diseases who cannot tolerate radiation therapy; Patients allergic to glutamine and thalidomide; Patients receiving secondary radiation therapy to the oral area; Pregnant women (confirmed by blood or urine HCG testing) or breastfeeding women, or participants of childbearing age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female participants) until at least 6 months after the last trial treatment; Patients with underlying peripheral neuropathy; Individuals deemed by the researcher to be inappropriate for participation in this study; Unwilling to participate in this study or unable to sign informed consent.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: glutamine combined with thalidomide<br>L-Glutamine: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take three times a day, two tablets each time; once in the morning, once in the afternoon, and once in the evening. Thalidomide: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take orally at 100mg, once every evening. | Drug: glutamine combined with thalidomide<br>* Patients received glutamine combined with thalidomide from the beginning of radiotherapy to one week after radiotherapy.<br>* Other names: GT group;|
| Active Comparator: glutamine alone<br>L-Glutamine: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take three times a day, two tablets each time; once in the morning, once in the afternoon, and once in the evening. | Drug: glutamine alone<br>* Patients received glutamine alone from the beginning of radiotherapy to one week after radiotherapy.<br>* Other names: G group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median time for the occurrence of Grade 2 radiation-induced oral mucositis | Median time for the occurrence of Grade 2 radiation-induced oral mucositis | during radiotherapy up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence rate of ≥grade 2 oral mucositis | incidence rate of ≥grade 2 oral mucositis | during radiotherapy up to 4 weeks | 
| Body mass index | <18.5kg/m2 indicates underweight, 18.5kg/m2-23.9kg/m2 indicates normal weight, >23.9kg/m2 indicates obesity. | during radiotherapy up to 4 weeks | 
| QOL | Out of a total of 60 points, a score less than 20 indicates extremely poor quality of life; 21-30 points indicates poor quality of life; 31-40 points indicates average quality of life; 41-50 points indicates relatively good quality of life; 51-60 points indicates good quality of life. | during radiotherapy up to 4 weeks | 
| adverse effects | adverse effects | during radiotherapy up to 4 weeks |