Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.
1 other identifier
interventional
40
1 country
1
Brief Summary
Effect of Live Combined Bifidobacterium,Lactobacillus and Enterococcus Capsules on Oral Mucositis in Nasopharyngeal Carcinoma Patients Receiving Radiotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Mar 2017
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 10, 2017
CompletedFirst Submitted
Initial submission to the registry
March 31, 2017
CompletedFirst Posted
Study publicly available on registry
April 13, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 5, 2018
CompletedDecember 19, 2017
December 1, 2017
10 months
March 31, 2017
December 16, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
the incidence of Radiation Therapy Oncology Group grade 3 mucositis
confluent pseudomembranous mucosa
one year
Study Arms (3)
drug group
EXPERIMENTALlive Lactobacillus, Bifidobacterium and Enterococcus ( two pills two times a day)with radiotherapy and Chemotherapy
non-drug group
NO INTERVENTIONonly receiving radiotherapy and chemotherapy
healthy control group
NO INTERVENTIONInterventions
3 pills two times a day during the whole treatment
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- any immune system disease under high risk to antimicrobial agents such as Diabetes,infection disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
Related Publications (1)
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.
PMID: 33841399DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chunling Jiang, MD PHD
Jiangxi Provincial Cancer Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- head of Science and Euducation Division
Study Record Dates
First Submitted
March 31, 2017
First Posted
April 13, 2017
Study Start
March 10, 2017
Primary Completion
January 5, 2018
Study Completion
January 5, 2018
Last Updated
December 19, 2017
Record last verified: 2017-12