Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis

NCT06031012 | Completed Phase 3

• 1 other identifier: AFMMUChina-oral mucocitis
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mucositis Oral

Outcome Measures

Primary Outcomes (1)

• Median time for the occurrence of Grade 2 radiation-induced oral mucositis

  Median time for the occurrence of Grade 2 radiation-induced oral mucositis

  during radiotherapy up to 4 weeks

Secondary Outcomes (4)

• incidence rate of ≥grade 2 oral mucositis

  during radiotherapy up to 4 weeks

• Body mass index

  during radiotherapy up to 4 weeks

• QOL

  during radiotherapy up to 4 weeks

• adverse effects

  during radiotherapy up to 4 weeks

Study Arms (2)

glutamine combined with thalidomide

EXPERIMENTAL

glutamine: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take three times a day, two tablets each time; once in the morning, once in the afternoon, and once in the evening. Thalidomide: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take orally at 100mg, once every evening.

Drug: glutamine combined with thalidomide

glutamine alone

ACTIVE COMPARATOR

glutamine: Start oral administration on the first day of radiation therapy, continuing until one week after radiation therapy ends. Take three times a day, two tablets each time; once in the morning, once in the afternoon, and once in the evening.

Drug: glutamine alone

Interventions

glutamine combined with thalidomide DRUG

Patients received glutamine combined with thalidomide from the beginning of radiotherapy to one week after radiotherapy.

Also known as: GT group

glutamine combined with thalidomide

glutamine alone DRUG

Patients received glutamine alone from the beginning of radiotherapy to one week after radiotherapy.

Also known as: Cgroup

glutamine alone

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years old;
• Patients with postoperative oral malignant tumors confirmed by pathological histology or cytology and requiring radiotherapy;
• Patients who have received more than 45Gy of radiation in the oral area;
• ECOG PS (Eastern Cooperative Oncology Group Performance Status) score of 0-1;
• 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;
• 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)
• Basic liver function is normal: Serum total bilirubin ≤ 1.5×ULN; AST (Aspartate Aminotransferase) ≤ 2.5×ULN; ALT (Alanine Aminotransferase) ≤ 2.5×ULN.
• Signed written informed consent.

You may not qualify if:

• Participated in another interventional clinical trial within the last 30 days;
• Patients with severe underlying oral diseases who cannot tolerate radiation therapy;
• Patients allergic to glutamine and thalidomide;
• Patients receiving secondary radiation therapy to the oral area;
• 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;
• Patients with underlying peripheral neuropathy;
• Individuals deemed by the researcher to be inappropriate for participation in this study;
• Unwilling to participate in this study or unable to sign informed consent.

Sponsors & Collaborators

• Air Force Military Medical University, China: lead

Study Sites (1)

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

Xi'an, Shaanxi, 710032, China

Location

MeSH Terms

Conditions

Stomatitis

Interventions

Thalidomide; Glutamine

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phthalimides; Phthalic Acids; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Piperidones; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Isoindoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor of department of radiation oncology of XiJing hospital

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 11, 2023
• Study Start: September 15, 2023
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: March 12, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)