Thalidomide With or Without Probiotics in Radioactive Oral Mucositis

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

2021-09-20

Study Completion Date

2022-12-31

Brief Summary

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

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Detailed Description

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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.

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

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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probiotics group

Use thalidomide in combination with probiotics during radiotherapy and chemotherapy

Group Type EXPERIMENTAL

probiotics

Intervention Type OTHER

one times a day during the whole treatment

thalidomide group

Thalidomide is used only during 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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probiotics

one 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