Please sign in to follow a disease.
New combo could delay painful mouth sores in cancer radiation
NCT ID NCT06031012
First seen Jun 25, 2026 · Last updated Jul 02, 2026 · Updated 3 times
Summary
This study tested whether adding thalidomide to glutamine can delay the onset of severe mouth sores caused by radiation therapy. 138 oral cancer patients were randomly assigned to receive either the combination or glutamine alone during their radiation treatment. The main goal was to see how long it took for grade 2 mouth sores to appear.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- glutamine combined with thalidomide
- What this could lead to
- If it works, this combination could help delay painful mouth sores during radiation, improving quality of life for oral cancer patients.
- What could go wrong
- This is a completed phase 3 trial with 138 participants, but results are not yet published. Thalidomide has known side effects like drowsiness and nerve damage, and the benefit over glutamine alone may be small.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
138 people
The number who actually took part.
- Started
-
Sep 2023
- Finished
-
Oct 2025
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age 18 to 75 years old; 2. Patients with locoregional advanced squamous cell carcinoma confirmed by pathological histology or cytology and requiring radiotherapy or concurrent chemoradiotherapy; 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Mucositis oral are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Department of Radiation Oncology, Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, 710032, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a spermidine gel soothe inflamed gums around dental implants?
- Can an immunotherapy combo shrink sinonasal tumors before surgery?
- Can a laser microscope diagnose skin cancer faster?
- Can a shorter radiation course tame side effects in head and neck cancer?
- Can Pre-Surgery immunotherapy prime the immune system to fight head and neck cancer?
- Glowing cancer cells: a new way to see tumors during surgery?