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Head and Neck CancerPhase 3NCT00814359

Magic Mouthwash Plus Sucralfate Versus Benzydamine Hydrochloride for the Treatment of Radiation-induced Mucositis

A Phase 3 study testing Combination of Magic Mouthwash Plus Sucralfate and 0.15% Benzydamine HCl in people with Head and Neck Cancer and Mucositis, run by Juravinski Cancer Centre Foundation at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Radiation treatment is very effective for treating cancers of the head and neck, however, during the course of treatment, it is common for patients to experience soreness of their mouth and throat due to the radiation. When radiation causes inflammation of the inside of the mouth, it is called 'mucositis'. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Cancer, Mucositis
What is being tested?
Combination of Magic Mouthwash Plus Sucralfate and 0.15% Benzydamine HCl
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
67 participants
Where
1 siteCanada
Study dates
May 2009to Sep 2010
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Histologically proven squamous cell carcinoma of the head and neck.
  • Receiving 6 or more weeks of external beam radiotherapy to a treatment volume that includes mucosal surfaces of the head and neck.

Who cannot join

  • Age less than 18 years
  • ECOG Performance Score 2 or higher
  • Patient is unable to understand the protocol and/or unable to provide informed consent
  • Patient is unable or unwilling to complete the questionnaires which are written in English.
  • Prior radiation to the head and neck region that would result in overlap of fields for the current study.
  • Plan to receive a radiation treatment volume that only includes the larynx and or hypopharynx with no planned treatment of locoregional lymph nodes.
Show all 12Show fewer
  • Plan to receive a concurrent chemotherapy agent other than cisplatin.
  • Plan to receive other investigational agents (eg. panitumumab).
  • Investigational agent of any kind within 30 days prior to randomization.
  • Concurrent administration of any other experimental intervention given for the purpose of preventing oral mucositis.
  • History of allergic or hypersensitivity reactions to any of the possible agents to be administered in the study.
  • Patients who are pregnant or lactating.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

Other trials in Canada

About this study

Official title: A Phase III Study of Magic Mouthwash Plus Sucralfate Versus Benzydamine HCl for Treatment of Radiation-induced Oral Mucositis in Head and Neck Cancer Patients.

Radiation treatment is very effective for treating cancers of the head and neck, however, during the course of treatment, it is common for patients to experience soreness of their mouth and throat due to the radiation. When radiation causes inflammation of the inside of the mouth, it is called 'mucositis'. There are several mouthwashes that are commonly used to prevent and treat mucositis, but none of these have been shown to be superior to another. This study is being conducted to see if using a combination of magic mouthwash and sucralfate is better than using a single mouthwash called benzydamine at decreasing the burden of mucositis.

Read the detailed description

Sixty patients with head and neck cancer being treated with 6 or more weeks of radiotherapy, will be randomly assigned to receive either a combination of magic mouthwash (diphenhydramine, dexamethasone and nystatin) plus sucralfate or benzydamine. Patients randomized to receive magic mouthwash plus sucralfate will rinse first with 5ml of the magic mouthwash for 2 minutes then swallow, followed by rinsing with 5ml of the 1g/5ml sucralfate for 2 minutes before swallowing, 4 times daily. Patients randomized to receive 0.15% benzydamine HCl will be instructed to rinse with 15ml of the solution for 2 minutes before expectorating, 4 times daily. Patients will start the mouthwash regimens prior to the initiation of radiotherapy, and stop 2 weeks after the completion of radiotherapy.

Being tested
Combination of Magic Mouthwash Plus Sucralfate, 0.15% Benzydamine HCl
Keywords
mucositis, radiation, magic mouthwash, sucralfate, benzydamine, diphenhydramine, dexamethasone, nystatin
Medical subject headings
Head and Neck Neoplasms, Mucositis

What participants receive

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

  • Combination of Magic Mouthwash Plus SucralfateDrug

    Also called Mucositis Mouthwash, Sulcrate

    Magic mouthwash will contain diphenhydramine powder 375mg, dexamethasone injection 2.8mg, and nystatin suspension 50ml (1000 units/ml) diluted to a total volume of 250ml with sterile water.

    The concentration of the sucralfate suspension will be 1g/5ml.

    Patients will be instructed to rinse first with 5ml of the magic mouthwash solution for 2 minutes then swallow, followed by rinsing with 5ml of the sucralfate suspension for 2 minutes before swallowing, repeating this 4 times daily, starting on the day prior to the initiation of radiotherapy, and stopping 2 weeks after the completion of radiotherapy.

  • 0.15% Benzydamine HClDrug

    Also called Tantum

    Patients will rinse with 15ml of 1.5mg/ml benzydamine HCl for 2 minutes then expectorate the solution, repeating this 4 times daily, starting on the day prior to the initiation of radiotherapy, and stopping 2 weeks after the completion of radiotherapy.

Study groups in NCT00814359
Study groupRoleWhat they receive
Magic Mouthwash Plus SucralfateExperimentalNot described
Receives: Drug: Combination of Magic Mouthwash Plus Sucralfate
Benzydamine HClActive comparatorNot described
Receives: Drug: 0.15% Benzydamine HCl

What is being measured

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

  1. The severity of patient-reported symptoms of mucositis as determined by the change in Oral Mucositis Weekly Questionnaire - Head and Neck Cancer (OMWQ-HN) score from baseline to 6 weeks.

    Measured: Baseline to 6 weeks after the initiation of radiotherapy.

Secondary outcomes (2)

  1. The severity of patient-reported symptoms of mucositis throughout the course radiotherapy as determined by the area under the curve for mean change in OMWQ-HN scores from baseline.

    Measured: Baseline to 10 weeks after initiating radiotherapy.

  2. Incidence of WHO Grade 3 or 4 oral mucositis after 4 weeks of radiotherapy.

    Measured: 4 weeks after initiating radiotherapy

Timeline

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

  1. First posted24 Dec 2008 (estimated)
  2. Study startMay 2009
  3. Primary completionSep 2010
  4. Study completionSep 2010

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
None (open label)
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00814359
Sponsor's protocol ID
MUCOSA-PROTECT
Status last verified
May 2009
First submitted
23 Dec 2008
Last updated
20 Jan 2011
Results posted
No
Data monitoring committee
No

Publications

  • Epstein JB, Silverman S Jr, Paggiarino DA, Crockett S, Schubert MM, Senzer NN, Lockhart PB, Gallagher MJ, Peterson DE, Leveque FG. Benzydamine HCl for prophylaxis of radiation-induced oral mucositis: results from a multicenter, randomized, double-blind, placebo-controlled clinical trial. Cancer. 2001 Aug 15;92(4):875-85. doi: 10.1002/1097-0142(20010815)92:43.0.co;2-1.

    PubMed 11550161

  • Epstein JB, Beaumont JL, Gwede CK, Murphy B, Garden AS, Meredith R, Le QT, Brizel D, Isitt J, Cella D. Longitudinal evaluation of the oral mucositis weekly questionnaire-head and neck cancer, a patient-reported outcomes questionnaire. Cancer. 2007 May 1;109(9):1914-22. doi: 10.1002/cncr.22620.

    PubMed 17377917

  • Wright JR, McKenzie M, DeAngelis C, Foroudi F, Paul N, Rajaraman M, Wong F, Wong R, Wong KS. Radiation induced mucositis: co-ordinating a research agenda. Clin Oncol (R Coll Radiol). 2003 Dec;15(8):473-7. doi: 10.1016/j.clon.2003.07.002.

    PubMed 14690003

  • Sutherland SE, Browman GP. Prophylaxis of oral mucositis in irradiated head-and-neck cancer patients: a proposed classification scheme of interventions and meta-analysis of randomized controlled trials. Int J Radiat Oncol Biol Phys. 2001 Mar 15;49(4):917-30. doi: 10.1016/s0360-3016(00)01456-5.

    PubMed 11240232

  • Sonis ST, Elting LS, Keefe D, Peterson DE, Schubert M, Hauer-Jensen M, Bekele BN, Raber-Durlacher J, Donnelly JP, Rubenstein EB; Mucositis Study Section of the Multinational Association for Supportive Care in Cancer; International Society for Oral Oncology. Perspectives on cancer therapy-induced mucosal injury: pathogenesis, measurement, epidemiology, and consequences for patients. Cancer. 2004 May 1;100(9 Suppl):1995-2025. doi: 10.1002/cncr.20162.

    PubMed 15108222

  • Stokman MA, Spijkervet FK, Boezen HM, Schouten JP, Roodenburg JL, de Vries EG. Preventive intervention possibilities in radiotherapy- and chemotherapy-induced oral mucositis: results of meta-analyses. J Dent Res. 2006 Aug;85(8):690-700. doi: 10.1177/154405910608500802.

    PubMed 16861284

  • Worthington HV, Clarkson JE, Eden OB. Interventions for preventing oral mucositis for patients with cancer receiving treatment. Cochrane Database Syst Rev. 2007 Oct 17;(4):CD000978. doi: 10.1002/14651858.CD000978.pub3.

    PubMed 17943748

  • Rothwell BR, Spektor WS. Palliation of radiation-related mucositis. Spec Care Dentist. 1990 Jan-Feb;10(1):21-5. doi: 10.1111/j.1754-4505.1990.tb01082.x.

    PubMed 1689512

  • Etiz D, Erkal HS, Serin M, Kucuk B, Hepari A, Elhan AH, Tulunay O, Cakmak A. Clinical and histopathological evaluation of sucralfate in prevention of oral mucositis induced by radiation therapy in patients with head and neck malignancies. Oral Oncol. 2000 Jan;36(1):116-20. doi: 10.1016/s1368-8375(99)00075-5.

    PubMed 10889930

  • Cengiz M, Ozyar E, Ozturk D, Akyol F, Atahan IL, Hayran M. Sucralfate in the prevention of radiation-induced oral mucositis. J Clin Gastroenterol. 1999 Jan;28(1):40-3. doi: 10.1097/00004836-199901000-00009.

    PubMed 9916664

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Combination of Magic Mouthwash Plus Sucralfate and 0.15% Benzydamine HCl in people with Head and Neck Cancer and Mucositis, run by Juravinski Cancer Centre Foundation at 1 site in Canada.

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 2 inclusion and 12 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: finished, as of the sponsor's last update on 20 Jan 2011. 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 Canada. 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. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The severity of patient-reported symptoms of mucositis as determined by the change in Oral Mucositis Weekly Questionnaire - Head and Neck Cancer (OMWQ-HN) score from baseline to 6 weeks. (time frame: Baseline to 6 weeks after the initiation of radiotherapy.). 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 NCT00814359, which also lists 10 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 20 Jan 2011.

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