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

The goal of this study is to compare glutamine combined with thalidomide with glutamine alone 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Mucositis Oral
• Intervention / Treatment: Drug: glutamine combined with thalidomide; Drug: glutamine alone

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Shaanxi
    • Xi'an, Shaanxi, China, 710032
      • Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: glutamine combined with thalidomide; L-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; Patients received glutamine combined with thalidomide from the beginning of radiotherapy to one week after radiotherapy.; Other Names: GT group
Active Comparator: glutamine alone; L-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; Patients received glutamine alone from the beginning of radiotherapy to one week after radiotherapy.; Other Names: G group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
incidence rate of ≥grade 2 oral mucositis	incidence rate of ≥grade 2 oral mucositis	during radiotherapy up to 4 weeks
Body mass index	<18.5kg/m2 indicates underweight, 18.5kg/m2-23.9kg/m2 indicates normal weight, >23.9kg/m2 indicates obesity.	during radiotherapy up to 4 weeks
QOL	Out of a total of 60 points, a score less than 20 indicates extremely poor quality of life; 21-30 points indicates poor quality of life; 31-40 points indicates average quality of life; 41-50 points indicates relatively good quality of life; 51-60 points indicates good quality of life.	during radiotherapy up to 4 weeks
adverse effects	adverse effects	during radiotherapy up to 4 weeks

Collaborators and Investigators

• Sponsor: Air Force Military Medical University, China

Study record dates

Study Major Dates

• Study Start (Estimated): September 15, 2023
• Primary Completion (Estimated): August 31, 2024
• Study Completion (Estimated): October 31, 2024

Study Registration Dates

• First Submitted: August 29, 2023
• First Submitted That Met QC Criteria: September 3, 2023
• First Posted (Actual): September 11, 2023

Study Record Updates

• Last Update Posted (Actual): September 11, 2023
• Last Update Submitted That Met QC Criteria: September 3, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Stomatognathic Diseases; Mouth Diseases; Mucositis; Stomatitis; Physiological Effects of Drugs; Anti-Infective Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Anti-Bacterial Agents; Leprostatic Agents; Thalidomide
• Other Study ID Numbers: AFMMUChina-oral mucocitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No