Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

September 19, 2021 updated by: Jiangxi Provincial Cancer Hospital

Study on Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Study on the application of thalidomide with or without probiotics in radioactive oral mucositis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Jiangxi
      • Nanchang, Jiangxi, China, 330029
        • Jiangxi Cancer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: probiotics group
Use thalidomide in combination with probiotics during radiotherapy and chemotherapy
Other: probiotics
one times a day during the whole treatment
NO_INTERVENTION: thalidomide group
Thalidomide is used only during radiotherapy and chemotherapy
NO_INTERVENTION: healthy control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of Radiation Therapy Oncology Group grade 3 mucositis
Time Frame: one month
Radiation oral mucositis
one month
the variaty of immune index
Time Frame: one month
CD3,CD4,CD8
one month
the variaty of immune index
Time Frame: one month
Hemoglobin
one month
the variaty of immune index
Time Frame: one month
lymphocyte ratio
one month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jiangxi Provincial Cancer Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 20, 2021

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

December 31, 2022

Study Registration Dates

First Submitted

August 31, 2021

First Submitted That Met QC Criteria

September 19, 2021

First Posted (ACTUAL)

September 28, 2021

Study Record Updates

Last Update Posted (ACTUAL)

September 28, 2021

Last Update Submitted That Met QC Criteria

September 19, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • jcl2021-8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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