Status:
RECRUITING
Compound Glutamine Enteric-Coated Capsules Combined with Thalidomide in Preventing Radiation-induced Oral Mucositis
Lead Sponsor:
Air Force Military Medical University, China
Conditions:
Mucositis Oral
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
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...
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 o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
September 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT06031012
Start Date
September 15 2023
End Date
October 31 2025
Last Update
February 26 2025
Active Locations (1)
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1
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032