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

NCT ID: NCT06031012

Last Updated: 2025-02-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 140 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-15
• Study Completion Date: 2025-10-31

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.

Conditions

Mucositis Oral

Study Design

• Allocation Method: NA
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

CGECC combined with thalidomide

Intervention Type: DRUG

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

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.

Group Type: ACTIVE_COMPARATOR

CGECC alone

Intervention Type: DRUG

Patients received CGECC alone from the beginning of radiotherapy to one week after radiotherapy.

Interventions

CGECC alone

Patients received CGECC alone from the beginning of radiotherapy to one week after radiotherapy.

Intervention Type: DRUG

CGECC combined with thalidomide

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

Intervention Type: DRUG

Other Intervention Names

GT group; Cgroup

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Air Force Military Medical University, China

OTHER

Sponsor Role: lead

Responsible Party

Mei Shi

clinical professor of department of radiation oncology of XiJing hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University

Xi'an, Shaanxi, China

Site Status: RECRUITING

Countries

China

Facility Contacts

Jian Zang, MD

Role: primary

zj81327@qq.com

+86-029-84775425

Jian Zang, M.D.,Ph.D

Role: backup

Other Identifiers

AFMMUChina-oral mucocitis

Identifier Type: -

Identifier Source: org_study_id