An interventional study of Lactobacillus, Bifidobacterium and Enterococcus in Oral Mucositis and Quality of Life, sponsored by Jiangxi Provincial Cancer Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-12-19.
Sponsored by Jiangxi Provincial Cancer Hospital · Not applicable, Interventional, and Prevention
Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.
Radiation-induced mucositis is an acute reaction of the mucosa of patients undergoing head and neck radiotherapy.It can lead to dose-limiting and debilitating side effect. There is no guideline on an acknowledged intervention that significantly reduces its severity. In the mucosa, the immune system's T cells and B cells have position-specific phenotypes and functions that are influenced by the microbiota. These cells play pivotal parts in the maintenance of immune homeostasis by suppressing responses to harmless antigens and by enforcing the integrity of the barrier functions of the gut mucosa.We designed a randomized trial of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules in patients with Nasopharyngeal Carcinoma. The aim of this study was to determine if regulating intestinal tract flora was effective in reducing the severity of radiation-induced mucositis in patients receiving radical dose radiotherapy. The effect of this intervention on a patient's general well-being was also investigated. The primary end-point of the study was the incidence of Radiation Therapy Oncology Group grade 3 mucositis.In 2017, 40 patients are estimated to be recruited into the study at Jiangxi Cancer Hospitals, China.20 patients were randomized to receive Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules and 20 to receive a placebo.
408 studies on the registry are indexed under Stomatitis; 85 are open to participants now.
This study's planned enrollment of 40 is below the median of 60 across 356 interventional studies indexed under Stomatitis.
Browse Stomatitis studies →Jiangxi Provincial Cancer Hospital is the lead sponsor of 34 studies on the registry; 19 are open to participants now.
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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
live Lactobacillus, Bifidobacterium and Enterococcus ( two pills two times a day)with radiotherapy and Chemotherapy
Other: Lactobacillus, Bifidobacterium and Enterococcus
only receiving radiotherapy and chemotherapy
3 pills two times a day during the whole treatment
the incidence of Radiation Therapy Oncology Group grade 3 mucositis
confluent pseudomembranous mucosa
Time frame: one year
Plan to share: Undecided
This study is status unknown, as verified in Dec 2017. You cannot join it, but the record below documents what was studied.
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Jiangxi Provincial Cancer Hospital