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Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis

Primary Purpose

Mucositis Oral

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
glutamine combined with thalidomide
glutamine alone
Sponsored by
Air Force Military Medical University, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mucositis Oral

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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): 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 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; 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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

glutamine combined with thalidomide

glutamine alone

Arm Description

L-Glutamine: 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.

L-Glutamine: 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

incidence rate of ≥grade 2 oral mucositis
incidence rate of ≥grade 2 oral mucositis
Body mass index
<18.5kg/m2 indicates underweight, 18.5kg/m2-23.9kg/m2 indicates normal weight, >23.9kg/m2 indicates obesity.
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.
adverse effects
adverse effects

Full Information

First Posted
August 29, 2023
Last Updated
September 3, 2023
Sponsor
Air Force Military Medical University, China
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1. Study Identification

Unique Protocol Identification Number
NCT06031012
Brief Title
Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis
Official Title
Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis in Patients Undergoing radiotherapy-a Multicenter, Open-label, Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
August 31, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Air Force Military Medical University, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mucositis Oral

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
glutamine combined with thalidomide
Arm Type
Experimental
Arm Description
L-Glutamine: 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.
Arm Title
glutamine alone
Arm Type
Active Comparator
Arm Description
L-Glutamine: 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.
Intervention Type
Drug
Intervention Name(s)
glutamine combined with thalidomide
Other Intervention Name(s)
GT group
Intervention Description
Patients received glutamine combined with thalidomide from the beginning of radiotherapy to one week after radiotherapy.
Intervention Type
Drug
Intervention Name(s)
glutamine alone
Other Intervention Name(s)
G group
Intervention Description
Patients received glutamine alone from the beginning of radiotherapy to one week after radiotherapy.
Primary Outcome Measure Information:
Title
Median time for the occurrence of Grade 2 radiation-induced oral mucositis
Description
Median time for the occurrence of Grade 2 radiation-induced oral mucositis
Time Frame
during radiotherapy up to 4 weeks
Secondary Outcome Measure Information:
Title
incidence rate of ≥grade 2 oral mucositis
Description
incidence rate of ≥grade 2 oral mucositis
Time Frame
during radiotherapy up to 4 weeks
Title
Body mass index
Description
<18.5kg/m2 indicates underweight, 18.5kg/m2-23.9kg/m2 indicates normal weight, >23.9kg/m2 indicates obesity.
Time Frame
during radiotherapy up to 4 weeks
Title
QOL
Description
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.
Time Frame
during radiotherapy up to 4 weeks
Title
adverse effects
Description
adverse effects
Time Frame
during radiotherapy up to 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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): 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 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; 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.
Facility Information:
Facility Name
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis

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