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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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14 January 2013 |
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Main ID: |
NCT01465308 |
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Date of registration:
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31/10/2011 |
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Primary sponsor: |
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Public title:
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The Effect of Honey on Xerostomia and Oral Mucositis
AC-H |
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Scientific title:
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A Randomized Control Trial for the Effect of Honey on Radiotherapy Induced Xerostomia and Oral Mucositis in Patients With Head and Neck Cancers |
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Date of first enrolment:
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August 2011 |
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Target sample size:
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60 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01465308 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
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Countries of recruitment
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Cyprus
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Contacts
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Name:
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Melanie Charalambous, PhD c |
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Address:
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Telephone:
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0035799514855 |
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Email:
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melanie.charalambous@cut.ac.cy |
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Affiliation:
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Name:
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Melanie Charalambous, PhDc |
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Address:
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Telephone:
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0035799514855 |
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Email:
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melanie.charalambous@cut.ac.cy |
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Affiliation:
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Name:
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Andreas Charalambous, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Cyprus University of Technology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients who receive radiotherapy (RT) to the oral cavity will be included in the
study.
- Patients with a confirmed histologic diagnosis of head and neck cancer referred to
non-palliative radiotherapy will enter into this trial.
- aged over 18
- receiving radiotherapy for at least four weeks
Exclusion Criteria:
- Allergic to honey
- confirmed and medically treated diabetes mellitus
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Head and Neck Cancer
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Intervention(s)
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Dietary Supplement: Honey mouthwash
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Other: Normal Saline
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Primary Outcome(s)
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Change from baseline in oral mucositis grades
[Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks]
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Change from baseline in Xerostomia grades
[Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks]
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Secondary Outcome(s)
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Change in baseline weight in one month
[Time Frame: 4 weeks]
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Changes in the General satisfaction of comfort
[Time Frame: 1 week, 2 week, 3 week, 4 week]
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Secondary ID(s)
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AC-HANHS-86
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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