Oral Mucositis, Quality of Life
Conditions
Brief summary
Study on the application of thalidomide with or without probiotics in radioactive oral mucositis
Detailed 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.
Interventions
OTHERprobiotics
one times a day during the whole treatment
Sponsors
Jiangxi Provincial Cancer Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the incidence of Radiation Therapy Oncology Group grade 3 mucositis | one month | Radiation oral mucositis |
| the variaty of immune index | one month | CD3,CD4,CD8 |
Countries
China
Contacts
Primary ContactChunling Jiang, MD PHD
Outcome results
None listed