Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Quality of Life Clinical Trial

Official title:

Study on Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05059613
• Other study ID #: jcl2021-8
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Mucositis
• Oral Mucositis
• Quality of Life
• Stomatitis

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