CompletedPhase 3

Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis

China138 participantsStarted 2023-09-15

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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):
✓. 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 criteria

✕. 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;

What they're measuring

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

Timeframe: during radiotherapy up to 4 weeks

Trial details

NCT IDNCT06031012

SponsorAir Force Military Medical University, China

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Mucositis Oral trials