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Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis

Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis in Patients Undergoing radiotherapy-a Multicenter, Open-label, Randomized Controlled Study

NCT06031012•Air Force Military Medical University, China

View on ClinicalTrials.gov

Summary

The goal of this study is to compare glutamine combined with thalidomide with glutamine in preventing radiation-induced oral mucositis. The aim of this study is to answer whether glutamine plus thalidomide could improve the median incidence time of grade 2 oral mucositis. Participants would be randomly divided into the two groups above mentioned.

Detailed Description

Explore the therapeutic efficacy of glutamine combined with Thalidomide as compared to glutamine alone in preventing radiation-induced oral mucositis. The primary research endpoint is the median time to the onset of Grade II oral mucositis, defined as the number of days from the start of radiation therapy to the occurrence of Grade II oral mucositis.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Age 18 to 75 years old;
•2. Patients with postoperative oral malignant tumors confirmed by pathological histology or cytology and requiring radiotherapy;
•3. Patients who have received more than 45Gy of radiation in the oral area;
•4. ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-1;
•5. Basic hematological indicators are normal: White blood cell count ≥ 4×10\^9/L; Absolute neutrophil count ≥ 1.5×10\^9/L; Platelets ≥ 100×10\^9/L; Hemoglobin ≥ 90 g/L;
•6. Basic renal function is normal: Serum creatinine ≤ 1.5×ULN (Upper Limit of Normal) or Creatinine Clearance Rate (CrCl) \> 60 mL/min (using the Cockcroft-Gault formula):
•For women: CrCl = (140 - age) × weight (kg) × 0.85 / (72 × Scr mg/dl) For men: CrCl = (140 - age) × weight (kg) × 1.00 / (72 × Scr mg/dl)
•7. Basic liver function is normal: Serum total bilirubin ≤ 1.5×ULN; AST (Aspartate Aminotransferase) ≤ 2.5×ULN; ALT (Alanine Aminotransferase) ≤ 2.5×ULN.
•8. Signed written informed consent.

Exclusion Criteria

•1. Participated in another interventional clinical trial within the last 30 days;
•2. Patients with severe underlying oral diseases who cannot tolerate radiation therapy;
•3. Patients allergic to glutamine and thalidomide;
•4. Patients receiving secondary radiation therapy to the oral area;
•5. Pregnant women (confirmed by blood or urine HCG testing) or breastfeeding women, or participants of childbearing age who are unwilling or unable to take effective contraceptive measures (applicable to both male and female participants) until at least 6 months after the last trial treatment;
•6. Patients with underlying peripheral neuropathy;
•7. Individuals deemed by the researcher to be inappropriate for participation in this study;
•8. Unwilling to participate in this study or unable to sign informed consent.

Locations (1)

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Key Dates

Start Date

September 15, 2023

Primary Completion Date

October 31, 2025

Completion Date

October 31, 2025

Last Updated

March 12, 2026

Enrollment

138

ACTUAL participants

Conditions

Mucositis Oral

Interventions

glutamine combined with thalidomide

DRUG

glutamine alone

DRUG

Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults

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Mucositis Oral

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ACTIVE_NOT_RECRUITINGPHASE1

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Head and Neck NeoplasmsMucositis Oral+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 12, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis

Inclusion Criteria

Exclusion Criteria

Low-level Laser Therapy in the Prevention of Chemotherapy-induced Mucositis in Children and Young Adults

Safety and Tolerability of the Use of Copaiba in Patients With Oral Cancer Submitted to Radiotherapy

Efficacy of Ketamine Mouthwash in the Management of Oral and Pharyngeal Toxicity Associated With Head and Neck Chemoradiotherapy: A Phase 2, Simon 2-stage Trial

GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer