Clinical trial · Interventional
Efficacy of Glutamine in Management of Radiation Mucositis
Efficacy of Glutamine in Management of Radiation Induced Mucositis in Patients With Head and Neck Cancer (A Randomized Controlled Clinical Study)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The goal of this \[ type of study: Clinical trial\] is to test effectiveness of glutamine in management of Radiation Induced Mucositis in head and neck cancer patients. The main question \[s\] \] is to \[ learn about, test, compare etc.\] it aims to answer are: 1. Is glutamine effective in management of Radiation Induced Mucositis? 2. Does Glutamine oral suspension affect the level of TGFβ1 in saliva of patients with radiation induced mucositis? participants will be asked to dissolve oral glutamine and maltodextrin in distalled water and swish and swallow three times daily during radiotherapy.
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 |
|---|---|---|---|
| Radiation-Induced Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glutamine | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (Test group):
- description
- Will include twenty patients receiving Glutamine oral suspension (5 grams of glutamine and 5 g maltodextrin dissolved in cold water) 30 min before a meal, 3 times per day through swish and swallow technique25 throughout the radiotherapy period.
- interventionNames
- Dietary Supplement: Glutamine
- type
- PLACEBO_COMPARATOR
- label
- Group II (Control group)
- description
- Included twenty patients receiving maltodextrin oral suspension (5 g maltodextrin dissolved in cold water) 30 min before a meal, 3 times per day through swish and swallow technique throughout the radiotherapy period along with general measures as well as analgesic drugs according to the WHO scale.
- interventionNames
- Dietary Supplement: Glutamine
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * a) Patients with a confirmed histologic diagnosis of H\&N malignancy who are referred to non-palliative radiotherapy in the oral cavity. b) Patient who is receiving radiation therapy with intensity modified radiotherapy IMRT or 3D techniques. c) Patients received 50-70 Gy of total radiation at the rate of 2 Gy/fraction daily and 5 fractions/week. d) Patient who received concurrent chemotherapy with radiotherapy e) Presence of Oral Mucositis f) Age 20-70 years old g) Willing to participate in the study h) Able to complete the study assessments Exclusion Criteria: * a) Have a confirmed or medically treated diabetes mellitus25 b) Radiotherapy within the last 6 months prior to this study c) Vulnerable patients
References
Publications (3)
- RESULTArutla M, Raghunath M, Deepika G, Jakkampudi A, Murthy HVV, Rao GV, Reddy DN, Talukdar R. Efficacy of enteral glutamine supplementation in patients with severe and predicted severe acute pancreatitis- A randomized controlled trial. Indian J Gastroenterol. 2019 Aug;38(4):338-347. doi: 10.1007/s12664-019-00962-7. Epub 2019 Oct 14. PMID 31612309
- RESULTFahr MJ, Kornbluth J, Blossom S, Schaeffer R, Klimberg VS. Harry M. Vars Research Award. Glutamine enhances immunoregulation of tumor growth. JPEN J Parenter Enteral Nutr. 1994 Nov-Dec;18(6):471-6. doi: 10.1177/0148607194018006471. PMID 7602720
- DERIVEDIbrahim SS, Hassanein FEA, Zaky HW, Gamal H. Clinical and biochemical assessment of the effect of glutamine in management of radiation induced oral mucositis in patients with head and neck cancer: Randomized controlled clinical trial. J Stomatol Oral Maxillofac Surg. 2024 Jun;125(3S):101827. doi: 10.1016/j.jormas.2024.101827. Epub 2024 Mar 15. PMID 38493953