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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03112837
• Other study ID #: yjcl2017
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2017
• Last updated: December 16, 2017
• Start date: March 10, 2017
• Est. completion date: January 5, 2018

Study information

• Verified date: December 2017
• Source: Jiangxi Provincial Cancer Hospital
• Contact: Chunling Jiang, MD PHD
• Phone: +8613979109200
• Email: jclil2002[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 5, 2018
• Est. primary completion date: January 5, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Mucositis
• Nasopharyngeal Neoplasms
• Oral Mucositis
• Quality of Life
• Stomatitis

Intervention

Other:
• Lactobacillus, Bifidobacterium and Enterococcus
3 pills two times a day during the whole treatment

Locations

Country	Name	City	State
China	Jiangxi Cancer Hospital	Nanchang	Jiangxi

Sponsors (1)

Lead Sponsor	Collaborator
Jiangxi Provincial Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the incidence of Radiation Therapy Oncology Group grade 3 mucositis	confluent pseudomembranous mucosa	one year