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

NCT ID: NCT03112837

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-10

Study Completion Date

2018-01-05

Brief Summary

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

Detailed Description

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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.

Conditions

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Oral Mucositis Quality of Life

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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drug group

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

Group Type EXPERIMENTAL

Lactobacillus, Bifidobacterium and Enterococcus

Intervention Type OTHER

3 pills two times a day during the whole treatment

non-drug group

only receiving radiotherapy and chemotherapy

Group Type NO_INTERVENTION

No interventions assigned to this group

healthy control group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Lactobacillus, Bifidobacterium and Enterococcus

3 pills two times a day during the whole treatment

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jiangxi Provincial Cancer Hospital

OTHER

Sponsor Role lead

Responsible Party

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Qiang Xu

head of Science and Euducation Division

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chunling Jiang, MD PHD

Role: PRINCIPAL_INVESTIGATOR

Jiangxi Provincial Cancer Hospital

Locations

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Jiangxi Cancer Hospital

Nanchang, Jiangxi, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chunling Jiang, MD PHD

Role: CONTACT

Phone: +8613979109200

Email: [email protected]

Facility Contacts

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Chunling Jiang, MD phd

Role: primary

References

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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.

Reference Type DERIVED
PMID: 33841399 (View on PubMed)

Other Identifiers

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yjcl2017

Identifier Type: -

Identifier Source: org_study_id