Back to resultsEffect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.
Primary Purpose
Oral Mucositis, Quality of Life
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Lactobacillus, Bifidobacterium and Enterococcus
Sponsored by
About this trial
This is an interventional prevention trial for Oral Mucositis
Eligibility Criteria
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
Sites / Locations
- Jiangxi Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
No Intervention
No Intervention
Arm Label
drug group
non-drug group
healthy control group
Arm Description
live Lactobacillus, Bifidobacterium and Enterococcus ( two pills two times a day)with radiotherapy and Chemotherapy
only receiving radiotherapy and chemotherapy
Outcomes
Primary Outcome Measures
the incidence of Radiation Therapy Oncology Group grade 3 mucositis
confluent pseudomembranous mucosa
Secondary Outcome Measures
Full Information
NCT ID
NCT03112837
First Posted
March 31, 2017
Last Updated
December 16, 2017
Sponsor
Jiangxi Provincial Cancer Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03112837
Brief Title
Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.
Official Title
Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
March 10, 2017 (Actual)
Primary Completion Date
January 5, 2018 (Anticipated)
Study Completion Date
January 5, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jiangxi Provincial Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Mucositis, Quality of Life
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
drug group
Arm Type
Experimental
Arm Description
live Lactobacillus, Bifidobacterium and Enterococcus ( two pills two times a day)with radiotherapy and Chemotherapy
Arm Title
non-drug group
Arm Type
No Intervention
Arm Description
only receiving radiotherapy and chemotherapy
Arm Title
healthy control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Lactobacillus, Bifidobacterium and Enterococcus
Intervention Description
3 pills two times a day during the whole treatment
Primary Outcome Measure Information:
Title
the incidence of Radiation Therapy Oncology Group grade 3 mucositis
Description
confluent pseudomembranous mucosa
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunling Jiang, MD PHD
Phone
+8613979109200
Email
jclil2002@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chunling Jiang, MD PHD
Organizational Affiliation
Jiangxi Provincial Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jiangxi Cancer Hospital
City
Nanchang
State/Province
Jiangxi
ZIP/Postal Code
330029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunling Jiang, MD phd
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
33841399
Citation
Xia C, Jiang C, Li W, Wei J, Hong H, Li J, Feng L, Wei H, Xin H, Chen T. A Phase II Randomized Clinical Trial and Mechanistic Studies Using Improved Probiotics to Prevent Oral Mucositis Induced by Concurrent Radiotherapy and Chemotherapy in Nasopharyngeal Carcinoma. Front Immunol. 2021 Mar 24;12:618150. doi: 10.3389/fimmu.2021.618150. eCollection 2021.
Results Reference
derived
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Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.
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