Oral Glutamine and Mucositis of Head and Neck Cancer Patients Undergoing Radiation

NCT02282839 | Unknown Phase 3

• 1 other identifier: TCVGH-1047004C
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Head and Neck Cancer; Mucositis

Keywords

Head and neck cancer; Glutamine; Oral mucositis; Quality of life

Outcome Measures

Primary Outcomes (1)

• Oral mucositis

  According to WHO grading system

  8 weeks

Secondary Outcomes (2)

• Pain status

  8 weeks

• Quality of life

  8 weeks

Study Arms (2)

Study group

ACTIVE COMPARATOR

Oral glutamine 10 g TID (total 30 g/day) one week before radiotherapy till the end of radiotherapy

Dietary Supplement: Glutamine

Control group

PLACEBO COMPARATOR

Placebo (Same ingredients without glutamine) one week before radiotherapy till the end of radiotherapy

Dietary Supplement: Placebo

Interventions

Glutamine DIETARY_SUPPLEMENT

Powder that soluble in water for drinking, 10g TID (total 30 g per day)

Also known as: AMINOPURE (Ajinomoto AmoniScience LLC)

Study group

Placebo DIETARY_SUPPLEMENT

Powder that provided by manufacturer with the same ingredients yet without glutamine, TID use

Control group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Head and neck cancer patients scheduled to receive radiotherapy with or without chemotherapy

You may not qualify if:

• Prior radiotherapy to the head and neck region
• Severe liver or renal disease
• Reye's syndrome
• Allergy to glutamine
• Reluctant to join the study

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Department of Otolaryngology Head Neck Surgery, Taichung Veterans General Hospital

Taichung, Taiwan, 40705, Taiwan

RECRUITING

Related Publications (11)

• Bardy 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 BACKGROUND

• Wu 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 BACKGROUND

• Nicolatou-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 BACKGROUND

• Lin 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 BACKGROUND

• Kazemian 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 BACKGROUND

• Gautam 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.

  PMID: 23224689 BACKGROUND

• Le QT, Kim HE, Schneider CJ, Murakozy G, Skladowski K, Reinisch S, Chen Y, Hickey M, Mo M, Chen MG, Berger D, Lizambri R, Henke M. Palifermin reduces severe mucositis in definitive chemoradiotherapy of locally advanced head and neck cancer: a randomized, placebo-controlled study. J Clin Oncol. 2011 Jul 10;29(20):2808-14. doi: 10.1200/JCO.2010.32.4095. Epub 2011 Jun 13.

  PMID: 21670453 BACKGROUND

• Ferreira PR, Fleck JF, Diehl A, Barletta D, Braga-Filho A, Barletta A, Ilha L. Protective effect of alpha-tocopherol in head and neck cancer radiation-induced mucositis: a double-blind randomized trial. Head Neck. 2004 Apr;26(4):313-21. doi: 10.1002/hed.10382.

  PMID: 15054734 BACKGROUND

• Cerchietti LC, Navigante AH, Lutteral MA, Castro MA, Kirchuk R, Bonomi M, Cabalar ME, Roth B, Negretti G, Sheinker B, Uchima P. Double-blinded, placebo-controlled trial on intravenous L-alanyl-L-glutamine in the incidence of oral mucositis following chemoradiotherapy in patients with head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2006 Aug 1;65(5):1330-7. doi: 10.1016/j.ijrobp.2006.03.042. Epub 2006 Jun 9.

  PMID: 16765532 BACKGROUND

• Peterson DE, Jones JB, Petit RG 2nd. Randomized, placebo-controlled trial of Saforis for prevention and treatment of oral mucositis in breast cancer patients receiving anthracycline-based chemotherapy. Cancer. 2007 Jan 15;109(2):322-31. doi: 10.1002/cncr.22384.

  PMID: 17154160 BACKGROUND

• Aquino VM, Harvey AR, Garvin JH, Godder KT, Nieder ML, Adams RH, Jackson GB, Sandler ES. A double-blind randomized placebo-controlled study of oral glutamine in the prevention of mucositis in children undergoing hematopoietic stem cell transplantation: a pediatric blood and marrow transplant consortium study. Bone Marrow Transplant. 2005 Oct;36(7):611-6. doi: 10.1038/sj.bmt.1705084.

  PMID: 16086046 BACKGROUND

MeSH Terms

Conditions

Head and Neck Neoplasms; Mucositis; Stomatitis

Interventions

Glutamine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Basic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Diamino; Amino Acids, Neutral

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: October 31, 2014
• First Posted: November 4, 2014
• Study Start: January 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2017
• Last Updated: November 4, 2015

Record last verified: 2015-11

Locations

TW (1)