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Head and Neck CancerPhase 3NCT02282839

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

A Phase 3 study testing Glutamine in people with Head and Neck Cancer and Mucositis, run by Taichung Veterans General Hospital at 1 site in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Head and Neck Cancer, Mucositis
What is being tested?
Glutamine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteTaiwan
Study dates
Jan 2015to Dec 2017
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site, 1 recruiting

  • Department of Otolaryngology Head Neck Surgery, Taichung Veterans General Hospital

    Taichung, Taiwan, 40705

    Shih-An Liu, MD, +886-4-23592525 ext. 5401, saliu@vghtc.gov.tw

    Recruiting

Other trials in Taiwan

About this study

Official title: The Influence of Glutamine on the Side Effects of Chemo-radiation in Head and Neck Cancer Patients - A Randomized Controlled Trial

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.

Read the detailed description

Chemotherapy and radiotherapy are important therapeutic modalities for head and neck cancer patients. Oral mucositis is a common comorbidity during chemotherapy and radiotherapy. It was reported that 30-60% of patients underwent chemotherapy and over 90% of patients receiving radiotherapy had oral mucositis. Oral mucositis not only reduces the quality of life of cancer patients during therapy but also causes dysphagia and poor nutritional status. Severe oral mucositis may necessitate unplanned gaps between treatment which can undermine the chance of local control.

In terms of management of oral mucositis, maintaining of oral hygiene and avoid infection are essential manner. Topical agents such as sucralfate, benzydamine, antifungal drugs, vitamin E and treatment using laser were studied in the management of oral mucositis. Previous studies indicated the glutamine significantly reduced the incidence and severity of oral mucositis in patients underwent chemotherapy and bone marrow transplantation. However, few studies discussed the effect of glutamine on the impact of oral mucositis in head and neck cancer patients receiving radiotherapy with/without chemotherapy.

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 while the control group will receive placebo during radiotherapy. The severity of oral mucositis (WHO grading system, every week), pain status (visual analogue scale, every week), quality of life questionnaires (before, during and after radiotherapy) will also be documented. The differences between the two groups will be analyzed.

Being tested
Glutamine, Placebo
Keywords
Head and neck cancer, Glutamine, Oral mucositis, Quality of life
Medical subject headings
Head and Neck Neoplasms, Mucositis, Stomatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GlutamineDietary supplement

    Also called AMINOPURE (Ajinomoto AmoniScience LLC)

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

  • PlaceboDietary supplement

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

Study groups in NCT02282839
Study groupRoleWhat they receive
Study groupActive comparatorOral glutamine 10 g TID (total 30 g/day) one week before radiotherapy till the end of radiotherapy
Receives: Dietary Supplement: Glutamine
Control groupPlacebo comparatorPlacebo (Same ingredients without glutamine) one week before radiotherapy till the end of radiotherapy
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Oral mucositis

    According to WHO grading system

    Measured: 8 weeks

Secondary outcomes (2)

  1. Pain status

    Pain status by visual analog scale

    Measured: 8 weeks

  2. Quality of life

    Washington University Quality of life questionaire

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2014 (estimated)
  2. Study startJan 2015
  3. Primary completionDec 2016 (estimated)
  4. Study completionDec 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02282839
Sponsor's protocol ID
TCVGH-1047004C
Status last verified
Nov 2015
First submitted
31 Oct 2014
Last updated
4 Nov 2015
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21636188

  • 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.

    PubMed 20826029

  • 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.

    PubMed 15947956

  • 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.

    PubMed 20574929

  • 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.

    PubMed 19267733

  • 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.

    PubMed 23224689

  • 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.

    PubMed 21670453

  • 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.

    PubMed 15054734

  • 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.

    PubMed 16765532

  • 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.

    PubMed 17154160

  • 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.

    PubMed 16086046

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Glutamine in people with Head and Neck Cancer and Mucositis, run by Taichung Veterans General Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oral mucositis (time frame: 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02282839, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2015.

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