Using Glutamine Capsules and Thalidomide to Prevent Oral Mucositis from Radiation
Compound Glutamine Enteric-Coated Capsules Combined with Thalidomide in Preventing Radiation-induced Oral Mucositis in Patients Undergoing Radiotherapy-a Multicenter, Open-label, Randomized Controlled Study
This study is testing if taking glutamine capsules with thalidomide can help prevent mouth sores caused by radiation in patients receiving treatment for oral cancer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Air Force Military Medical University, China Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Xi'an, Shaanxi) |
| Trial ID | NCT06031012 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness of Compound Glutamine Enteric-Coated Capsules (CGECC) combined with thalidomide compared to CGECC alone in preventing radiation-induced oral mucositis in patients undergoing radiotherapy for oral malignant tumors. Participants will be randomly assigned to receive either the combination treatment or CGECC alone. The primary endpoint is to measure the median time to the onset of Grade II oral mucositis, which is defined as the number of days from the start of radiation therapy until the occurrence of this condition.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with postoperative oral malignant tumors requiring radiotherapy and who have received more than 45Gy of radiation in the oral area.
Not a fit: Patients with conditions that prevent normal renal or liver function, or those with an ECOG performance status greater than 1, may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence and severity of oral mucositis in patients receiving radiation therapy.
How similar studies have performed: While there have been studies on preventing oral mucositis, the specific combination of CGECC and thalidomide is a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Xi'an, Shaanxi
- Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University — Xi'an, Shaanxi, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.