Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Sponsor

Jiangxi Provincial Cancer Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05059613

Collaborator

(none)

Enrollment

Location

Arms

15.3

Anticipated Duration (Months)

2.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Oral Mucositis Quality of Life	Other: probiotics	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

Study on Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

Anticipated Study Start Date :

Sep 20, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

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 healthy control 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

healthy control group

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jiangxi Cancer Hospital	Nanchang	Jiangxi	China	330029

Sponsors and Collaborators

Jiangxi Provincial Cancer Hospital

Investigators

Principal Investigator: Chunling Jiang, MD PHD, Jiangxi Provincial Cancer Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jiangxi Provincial Cancer Hospital

ClinicalTrials.gov Identifier:

NCT05059613

Other Study ID Numbers:

jcl2021-8

First Posted:

Sep 28, 2021

Last Update Posted:

Sep 28, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Mucositis

Stomatitis

Study Results

No Results Posted as of Sep 28, 2021