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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05059613
Other study ID # jcl2021-8
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date September 20, 2021
Est. completion date December 31, 2022

Study information

Verified date September 2021
Source Jiangxi Provincial Cancer Hospital
Contact Chunling Jiang, MD PHD
Phone 13979109200
Email jclil2002@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 40
Est. completion date December 31, 2022
Est. primary completion date December 31, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
probiotics
one times a day during the whole treatment

Locations

Country Name City State
China Jiangxi Cancer Hospital Nanchang Jiangxi

Sponsors (1)

Lead Sponsor Collaborator
Jiangxi Provincial Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary the incidence of Radiation Therapy Oncology Group grade 3 mucositis Radiation oral mucositis one month
Primary the variaty of immune index CD3,CD4,CD8 one month
Primary the variaty of immune index Hemoglobin one month
Primary the variaty of immune index lymphocyte ratio one month
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