Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- the incidence of Radiation Therapy Oncology Group grade 3 mucositis
Study Overview
Brief Summary
Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.
Detailed 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
drug group
live Lactobacillus, Bifidobacterium and Enterococcus ( two pills two times a day)with radiotherapy and Chemotherapy
Intervention: Lactobacillus, Bifidobacterium and Enterococcus (Other)
non-drug group
only receiving radiotherapy and chemotherapy
healthy control group
Outcomes
Primary Outcomes
the incidence of Radiation Therapy Oncology Group grade 3 mucositis
Time Frame: one year
confluent pseudomembranous mucosa
Secondary Outcomes
No secondary outcomes reported
Investigators
Qiang Xu
head of Science and Euducation Division
Jiangxi Provincial Cancer Hospital