The Effect of Honey on Xerostomia and Oral Mucositis (AC-H)
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ClinicalTrials.gov Identifier: NCT01465308 |
Recruitment Status :
Completed
First Posted : November 4, 2011
Last Update Posted : October 8, 2014
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Sponsor:
Cyprus University of Technology
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology
Tracking Information | ||||
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First Submitted Date ICMJE | October 31, 2011 | |||
First Posted Date ICMJE | November 4, 2011 | |||
Last Update Posted Date | October 8, 2014 | |||
Study Start Date ICMJE | August 2011 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | The Effect of Honey on Xerostomia and Oral Mucositis | |||
Official Title ICMJE | A Randomized Control Trial for the Effect of Honey on Radiotherapy Induced Xerostomia and Oral Mucositis in Patients With Head and Neck Cancers | |||
Brief Summary | The purpose of this study is to determine whether the use of pure honey will help in the treatment of radiation induced xerostomia and oral mucositis (symptom management) | |||
Detailed Description | Radiation-induced mucositis is a normal acute side effect of radiotherapy treatment. Exposure of ionising radiation to oral, pharyngeal and laryngeal mucosa gives rise to radiation epithelitis towards the second and third weeks of conventional fractionated radiotherapy. Likewise, salivary flow may decrease by approximately 50% during the first week of radiotherapy and upwards of 80% by the seventh week of treatment. Acute radiation-induced xerostomia is associated with inflammatory reaction. The study will include an intervention and a control group, one receiving honey prior and after the radiotherapy and the other group not receiving honey at all. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single (Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Head and Neck Cancer | |||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
72 | |||
Original Estimated Enrollment ICMJE |
40 | |||
Actual Study Completion Date ICMJE | October 2014 | |||
Actual Primary Completion Date | September 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Cyprus | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01465308 | |||
Other Study ID Numbers ICMJE | AC-HANHS-86 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Dr. Andreas Charalambous, Cyprus University of Technology | |||
Study Sponsor ICMJE | Cyprus University of Technology | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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PRS Account | Cyprus University of Technology | |||
Verification Date | October 2014 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |