Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.

Jiangxi Provincial Cancer Hospital

Status: Unknown

Conditions: Quality of Life; Oral Mucositis

Treatments: Other: Lactobacillus, Bifidobacterium and Enterococcus

Study type: Interventional

Funder types: Other

Identifiers

NCT03112837

yjcl2017

Details and patient eligibility

About

Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 60 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: Triple Blind

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40 participants in 3 patient groups

drug group

Experimental group

Description:

live Lactobacillus, Bifidobacterium and Enterococcus ( two pills two times a day)with radiotherapy and Chemotherapy

Treatment:

Other: Lactobacillus, Bifidobacterium and Enterococcus

non-drug group

No Intervention group

Description:

only receiving radiotherapy and chemotherapy

healthy control group

No Intervention group