Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis

Mucositis Oral Clinical Trial

Official title:

Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis in Patients Undergoing radiotherapy-a Multicenter, Open-label, Randomized Controlled Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06031012
• Other study ID #: AFMMUChina-oral mucocitis
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: September 15, 2023
• Est. completion date: October 31, 2024

Study information

• Verified date: September 2023
• Source: Air Force Military Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: October 31, 2024
• Est. primary completion date: August 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mucositis
• Mucositis Oral
• Stomatitis

Intervention

Drug:
• glutamine combined with thalidomide
Patients received glutamine combined with thalidomide from the beginning of radiotherapy to one week after radiotherapy.
• glutamine alone
Patients received glutamine alone from the beginning of radiotherapy to one week after radiotherapy.

Locations

Country	Name	City	State
China	Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	incidence rate of =grade 2 oral mucositis	incidence rate of =grade 2 oral mucositis	during radiotherapy up to 4 weeks
Secondary	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
Secondary	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
Secondary	adverse effects	adverse effects	during radiotherapy up to 4 weeks