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New combo could delay painful mouth sores in cancer radiation

NCT ID NCT06031012

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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.

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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

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