Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Jiangxi Provincial Cancer Hospital

Status: Unknown

Conditions: Quality of Life; Oral Mucositis

Treatments: Other: probiotics

Study type: Interventional

Funder types: Other

Identifiers

NCT05059613

jcl2021-8

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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40 participants in 3 patient groups

probiotics group

Experimental group

Description:

Use thalidomide in combination with probiotics during radiotherapy and chemotherapy

Treatment:

Other: probiotics

thalidomide group

No Intervention group

Description:

Thalidomide is used only during radiotherapy and chemotherapy

healthy control group

No Intervention group

Description:

healthy control group