Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Study Overview
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Brief Summary
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Study on the application of thalidomide with or without probiotics in radioactive oral mucositis

Detailed Description
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Radiation oral mucositis is an acute mucous membrane reaction in patients undergoing radiotherapy of the head and neck. It can cause dose limitation and debilitating side effects. There is no accepted guideline that can significantly reduce its severity. In the mucosa, T and B cells of the immune system have location-specific phenotypes and functions that are influenced by the microbiome. These cells play a key role in maintaining immune homeostasis by inhibiting responses to harmless antigens and enhancing the integrity of intestinal mucosal barrier function. We designed a clinical study of thalidomide with or without probiotics in radioactive oral mucositis. The aim of this study was to determine whether regulation of intestinal flora can effectively reduce the severity of radiation-induced mucositis in patients undergoing radical radiation therapy. The researchers also investigated the effect of the intervention on patients' general well-being. The primary endpoint was the incidence of grade 3 mucositis in the radiotherapy oncology group. In 2021, an estimated 40 patients were enrolled in the study at Jiangxi Cancer Hospital in China.

Official Title
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Study on Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Conditions
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Oral Mucositis, Quality of Life

Intervention / Treatment
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* Other: probiotics


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Karnofsky score ≥80 ,newly diagnosed NPC without distant metastasis, confirmed by pathology without any other malignant disease history ,no any other anti-cancer treatment for NPC previously ,received radiotherapy and chemotherapy at our Cancer Center Exclusion Criteria: any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotics group<br>Use thalidomide in combination with probiotics during radiotherapy and chemotherapy | Other: probiotics<br>* one times a day during the whole treatment<br>|
| No Intervention: thalidomide group<br>Thalidomide is used only during radiotherapy and chemotherapy | |
| No Intervention: healthy control group<br>healthy control group | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the incidence of Radiation Therapy Oncology Group grade 3 mucositis | Radiation oral mucositis | one month | 
| the variaty of immune index | CD3,CD4,CD8 | one month | 
| the variaty of immune index | Hemoglobin | one month | 
| the variaty of immune index | lymphocyte ratio | one month |