Clinical trial · Interventional
Oral Glutamine and Mucositis of Head and Neck Cancer Patients Undergoing Radiation
The Influence of Glutamine on the Side Effects of Chemo-radiation in Head and Neck Cancer Patients - A Randomized Controlled Trial
- 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)
This study will enroll 60 consecutive patients who are scheduled to receive radiotherapy with/without chemotherapy due to head and neck cancers. Basic data will be recorded along with tumor related variables. Then they will be divided randomly into study group and control group. The study group will receive oral glutamine during radiotherapy while the control group will receive placebo during radiotherapy. The severity of oral mucositis (WHO grading system), pain status (visual analogue scale), quality of life questionnaires will also be documented. The differences between the two groups will be analyzed.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Mucositis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Glutamine | Dietary Supplement | — | UNRESOLVED |
| Placebo | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Study group
- description
- Oral glutamine 10 g TID (total 30 g/day) one week before radiotherapy till the end of radiotherapy
- interventionNames
- Dietary Supplement: Glutamine
- type
- PLACEBO_COMPARATOR
- label
- Control group
- description
- Placebo (Same ingredients without glutamine) one week before radiotherapy till the end of radiotherapy
- interventionNames
- Dietary Supplement: Placebo
Primary outcomes (1)
- measure
- Oral mucositis
- timeFrame
- 8 weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Head and neck cancer patients scheduled to receive radiotherapy with or without chemotherapy Exclusion Criteria: * Prior radiotherapy to the head and neck region * Severe liver or renal disease * Reye's syndrome * Allergy to glutamine * Reluctant to join the study
References
Publications (11)
- BACKGROUNDBardy J, Molassiotis A, Ryder WD, Mais K, Sykes A, Yap B, Lee L, Kaczmarski E, Slevin N. A double-blind, placebo-controlled, randomised trial of active manuka honey and standard oral care for radiation-induced oral mucositis. Br J Oral Maxillofac Surg. 2012 Apr;50(3):221-6. doi: 10.1016/j.bjoms.2011.03.005. Epub 2011 Jun 1. PMID 21636188
- BACKGROUNDWu SX, Cui TT, Zhao C, Pan JJ, Xu BY, Tian Y, Cui NJ. A prospective, randomized, multi-center trial to investigate Actovegin in prevention and treatment of acute oral mucositis caused by chemoradiotherapy for nasopharyngeal carcinoma. Radiother Oncol. 2010 Oct;97(1):113-8. doi: 10.1016/j.radonc.2010.08.003. Epub 2010 Sep 7. PMID 20826029
- BACKGROUNDNicolatou-Galitis O, Velegraki A, Sotiropoulou-Lontou A, Dardoufas K, Kouloulias V, Kyprianou K, Kolitsi G, Skarleas C, Pissakas G, Papanicolaou VS, Kouvaris J. Effect of fluconazole antifungal prophylaxis on oral mucositis in head and neck cancer patients receiving radiotherapy. Support Care Cancer. 2006 Jan;14(1):44-51. doi: 10.1007/s00520-005-0835-2. Epub 2005 Jun 10. PMID 15947956
- BACKGROUNDLin YS, Lin LC, Lin SW, Chang CP. Discrepancy of the effects of zinc supplementation on the prevention of radiotherapy-induced mucositis between patients with nasopharyngeal carcinoma and those with oral cancers: subgroup analysis of a double-blind, randomized study. Nutr Cancer. 2010;62(5):682-91. doi: 10.1080/01635581003605532. PMID 20574929
- BACKGROUNDKazemian A, Kamian S, Aghili M, Hashemi FA, Haddad P. Benzydamine for prophylaxis of radiation-induced oral mucositis in head and neck cancers: a double-blind placebo-controlled randomized clinical trial. Eur J Cancer Care (Engl). 2009 Mar;18(2):174-8. doi: 10.1111/j.1365-2354.2008.00943.x. PMID 19267733
- BACKGROUNDGautam AP, Fernandes DJ, Vidyasagar MS, Maiya AG, Nigudgi S. Effect of low-level laser therapy on patient reported measures of oral mucositis and quality of life in head and neck cancer patients receiving chemoradiotherapy--a randomized controlled trial. Support Care Cancer. 2013 May;21(5):1421-8. doi: 10.1007/s00520-012-1684-4. Epub 2012 Dec 8.