Clinical trial · Interventional
Randomized Trial of Glutamine in Patients With Mucositis or Esophagitis
Randomized, Double Blinded Placebo-Controlled Study of Glutamine in Patients With Oral Mucositis on an mTOR Inhibitor-based Regimen or Esophagitis on a Regimen Receiving Radiation to the Esophagus
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Per PI
Summary
Brief summary (as posted)
The goal of this clinical research study is to learn if glutamine can help control and prevent sores, blisters, or inflammation in your mouth or esophagus due to your current treatment. In this study, glutamine will be compared to a placebo. A placebo is not a drug. It looks like the drug but is not designed to treat any disease or illness. It is designed to be compared with a study drug to learn if the study drug has any real effect.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Cancers | Malignant Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glutamine | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- type
- PLACEBO_COMPARATOR
- label
- mTOR Inhibitor Patient Group - Placebo
- description
- Participants receive placebo beginning on Day 1 of an mTOR inhibitor based therapy. Placebo taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.
- interventionNames
- Other: Placebo
- Behavioral: Questionnaires
- type
- EXPERIMENTAL
- label
- mTOR Inhibitor Patient Group - Glutamine
- description
- Glutamine taken as a sugary drink by mouth. Participant will take the drink twice daily starting first day anti-cancer therapy received. Participant to swish the drink for 10 seconds and swallow. Four weeks of treatment constitute 1 cycle for participants on mTOR inhibitor therapy.
- interventionNames
- Drug: Glutamine
- Behavioral: Questionnaires
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: 1. Patients who will be initiating therapy with any investigator-initiated mTOR inhibitor based therapy in the Department of Investigational Cancer Therapeutics (Phase I Program) or initiating radiation therapy to the esophagus. 2. For the esophagitis arm, any patient with thoracic malignancies, which will receive radiation alone or concurrent chemo/radiation. Radiation dose must be \>/= 45 Gy. For the esophagitis arm, induction chemotherapy is allowed. 3. Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures. 4. Patients must be \>/= 17 years of age. 5. Females of childbearing potential must have a negative pregnancy test. Sexually active patients must agree to use contraception prior to, during, and 30 days after last dose. Exclusion Criteria: 1\) Patients currently receiving therapy for mucositis.
References
Publications (1)
- DERIVEDAlshawa A, Cadena AP, Stephen B, Reddy A, Mendoza TR, McQuinn L, Lawhorn K, Zarifa A, Bernhardt AM, Fessaheye S, Warneke CL, Chang JY, Naing A. Effects of glutamine for prevention of radiation-induced esophagitis: a double-blind placebo-controlled trial. Invest New Drugs. 2021 Aug;39(4):1113-1122. doi: 10.1007/s10637-021-01074-w. Epub 2021 Feb 13. PMID 33580845