Compound Glutamine Enteric-Coated Capsules Combined with Thalidomide in Preventing Radiation-induced Oral Mucositis

Phase 3

Recruiting

• Conditions: Mucositis Oral
• Interventions: Drug: CGECC combined with thalidomide; Drug: CGECC alone

• Registration Number: NCT06031012
• Lead Sponsor: Air Force Military Medical University, China

Brief Summary

The goal of this study is to compare Compound Glutamine Enteric-Coated Capsules (CGECC) combined with thalidomide with CGECC in preventing radiation-induced oral mucositis. The aim of this study is to answer whether CGECC 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 CGECC combined with Thalidomide as compared to CGECC 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 Timeline

• Study First Submitted: 2023-08-29
• Study First Submitted QC: 2023-09-03
• Study First Posted: 2023-09-11
• Study Start: 2023-09-15
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-24
• Last Update Posted: 2025-02-26
• Primary Completion: 2025-08-31
• Study Completion: 2025-10-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 140

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGECC combined with thalidomide	CGECC combined with thalidomide	CGECC: 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.
CGECC alone	CGECC alone	CGECC: 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.

Primary Outcome Measures

Name	Time	Method
Median time for the occurrence of Grade 2 radiation-induced oral mucositis	during radiotherapy up to 4 weeks	Median time for the occurrence of Grade 2 radiation-induced oral mucositis

Secondary Outcome Measures

Name	Time	Method
QOL	during radiotherapy up to 4 weeks	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.
incidence rate of ≥grade 2 oral mucositis	during radiotherapy up to 4 weeks	incidence rate of ≥grade 2 oral mucositis
Body mass index	during radiotherapy up to 4 weeks	\<18.5kg/m2 indicates underweight, 18.5kg/m2-23.9kg/m2 indicates normal weight, \>23.9kg/m2 indicates obesity.
adverse effects	during radiotherapy up to 4 weeks	adverse effects

Trial Locations

Locations (1)

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China