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Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Primary Purpose

Oral Mucositis, Quality of Life

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
probiotics
Sponsored by
Jiangxi Provincial Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Oral Mucositis

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

probiotics group

thalidomide group

healthy control group

Arm Description

Use thalidomide in combination with probiotics during radiotherapy and chemotherapy

Thalidomide is used only during radiotherapy and chemotherapy

healthy control group

Outcomes

Primary Outcome Measures

the incidence of Radiation Therapy Oncology Group grade 3 mucositis
Radiation oral mucositis
the variaty of immune index
CD3,CD4,CD8
the variaty of immune index
Hemoglobin
the variaty of immune index
lymphocyte ratio

Secondary Outcome Measures

Full Information

First Posted
August 31, 2021
Last Updated
September 19, 2021
Sponsor
Jiangxi Provincial Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05059613
Brief Title
Thalidomide With or Without Probiotics in Radioactive Oral Mucositis
Official Title
Study on Thalidomide With or Without Probiotics in Radioactive Oral Mucositis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 20, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Study on the application of thalidomide with or without probiotics in radioactive oral mucositis
Detailed Description
Radiation oral mucositis is an acute mucous membrane reaction in patients undergoing radiotherapy of the head and neck. It can cause dose limitation and debilitating side effects. There is no accepted guideline that can significantly reduce its severity. In the mucosa, T and B cells of the immune system have location-specific phenotypes and functions that are influenced by the microbiome. These cells play a key role in maintaining immune homeostasis by inhibiting responses to harmless antigens and enhancing the integrity of intestinal mucosal barrier function. We designed a clinical study of thalidomide with or without probiotics in radioactive oral mucositis. The aim of this study was to determine whether regulation of intestinal flora can effectively reduce the severity of radiation-induced mucositis in patients undergoing radical radiation therapy. The researchers also investigated the effect of the intervention on patients' general well-being. The primary endpoint was the incidence of grade 3 mucositis in the radiotherapy oncology group. In 2021, an estimated 40 patients were enrolled in the study at Jiangxi Cancer Hospital in China.

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
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
probiotics group
Arm Type
Experimental
Arm Description
Use thalidomide in combination with probiotics during radiotherapy and chemotherapy
Arm Title
thalidomide group
Arm Type
No Intervention
Arm Description
Thalidomide is used only during radiotherapy and chemotherapy
Arm Title
healthy control group
Arm Type
No Intervention
Arm Description
healthy control group
Intervention Type
Other
Intervention Name(s)
probiotics
Intervention Description
one times a day during the whole treatment
Primary Outcome Measure Information:
Title
the incidence of Radiation Therapy Oncology Group grade 3 mucositis
Description
Radiation oral mucositis
Time Frame
one month
Title
the variaty of immune index
Description
CD3,CD4,CD8
Time Frame
one month
Title
the variaty of immune index
Description
Hemoglobin
Time Frame
one month
Title
the variaty of immune index
Description
lymphocyte ratio
Time Frame
one month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 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
13979109200
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
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chunling Jiang, MD phd

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

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