Mucositis OralPhase 3NCT06031012
Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis
A Phase 3 study testing glutamine combined with thalidomide and glutamine alone in people with Mucositis Oral, run by Air Force Military Medical University, China at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Mucositis Oral
- What is being tested?
- glutamine combined with thalidomide and glutamine alone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 15 Sep 2023to 31 Oct 2025
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 75 years old;
- Patients with locoregional advanced squamous cell carcinoma confirmed by pathological histology or cytology and requiring radiotherapy or concurrent chemoradiotherapy;
- 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):
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032
About this study
Official title: Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis in Patients Undergoing radiotherapy-a Multicenter, Open-label, Randomized Controlled Study
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.
Read the 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.
- Conditions
- Mucositis Oral
- Being tested
- glutamine combined with thalidomide, glutamine alone
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
glutamine combined with thalidomideDrug
Also called GT group
Patients received glutamine combined with thalidomide from the beginning of radiotherapy to one week after radiotherapy.
glutamine aloneDrug
Also called Cgroup
Patients received glutamine alone from the beginning of radiotherapy to one week after radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| glutamine combined with thalidomide | Experimental | 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. Receives: Drug: glutamine combined with thalidomide |
| glutamine alone | Active comparator | 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. Receives: Drug: glutamine alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median time for the occurrence of Grade 2 radiation-induced oral mucositis
Median time for the occurrence of Grade 2 radiation-induced oral mucositis
Measured: during radiotherapy up to 4 weeks
Secondary outcomes (4)
incidence rate of ≥grade 3 oral mucositis
incidence rate of ≥grade 3 oral mucositis
Measured: during radiotherapy up to 4 weeks
Body mass index
<18.5kg/m2 indicates underweight, 18.5kg/m2-23.9kg/m2 indicates normal weight, >23.9kg/m2 indicates obesity.
Measured: during radiotherapy up to 4 weeks
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.
Measured: during radiotherapy up to 4 weeks
adverse effects
adverse effects
Measured: during radiotherapy up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start15 Sep 2023
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mucositis OralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Shi, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06031012
- Sponsor's protocol ID
- AFMMUChina-oral mucocitis
- Status last verified
- Jun 2026
- First submitted
- 29 Aug 2023
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Glutamine Combined With Thalidomide in Preventing Radiation-induced Oral Mucositis in Patients Undergoing radiotherapy-a Multicenter, Open-label, Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06031012
- Acronym / sponsor ID
- AFMMUChina-oral mucocitis
- Conditions
- Mucositis Oral
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Sep 2023 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 11 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| glutamine combined with thalidomide | Experimental | Drug: glutamine combined with thalidomideglutamine: 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. |
| glutamine alone | Active comparator | Drug: glutamine aloneglutamine: 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 to 75 years old;
- Patients with locoregional advanced squamous cell carcinoma confirmed by pathological histology or cytology and requiring radiotherapy or concurrent chemoradiotherapy;
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| glutamine combined with thalidomideAlso: GT groupPatients received glutamine combined with thalidomide from the beginning of radiotherapy to one week after radiotherapy. | Drug | glutamine combined with thalidomide |
| glutamine aloneAlso: CgroupPatients received glutamine alone from the beginning of radiotherapy to one week after radiotherapy. | Drug | glutamine alone |
Primary outcome
Median time for the occurrence of Grade 2 radiation-induced oral mucositis
Time frame: during radiotherapy up to 4 weeks
Median time for the occurrence of Grade 2 radiation-induced oral mucositis
4 secondary outcomes
incidence rate of ≥grade 3 oral mucositis
Time frame: during radiotherapy up to 4 weeks
Body mass index
Time frame: during radiotherapy up to 4 weeks
QOL
Time frame: during radiotherapy up to 4 weeks
adverse effects
Time frame: during radiotherapy up to 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing glutamine combined with thalidomide and glutamine alone in people with Mucositis Oral, run by Air Force Military Medical University, China at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median time for the occurrence of Grade 2 radiation-induced oral mucositis (time frame: during radiotherapy up to 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.