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The Effect of Honey on Xerostomia and Oral Mucositis (AC-H)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01465308
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : October 8, 2014
Sponsor:
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology

Tracking Information
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
 (submitted: November 2, 2011)
  • Change from baseline in Xerostomia grades [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ]
  • Change from baseline in oral mucositis grades [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 2, 2011)
  • Changes in the General satisfaction of comfort [ Time Frame: 1 week, 2 week, 3 week, 4 week ]
  • Change in baseline weight in one month [ Time Frame: 4 weeks ]
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
Condition  ICMJE Head and Neck Cancer
Intervention  ICMJE
  • Dietary Supplement: Honey mouthwash
    The patients in the intervention group will receive honey mouthwash 15 minutes before the radiotherapy session, 15 minutes after and 6 hours after the radiotherapy session
  • Other: Normal Saline
    Saline rinses 15 minutes before radiotherapy, 15 minutes after, and 6 hours after radiotherapy
Study Arms  ICMJE
  • Experimental: receiving Honey
    The patients will receive honey mouthwash rinses
    Intervention: Dietary Supplement: Honey mouthwash
  • Active Comparator: Saline mouthwash
    The patients in this group will receive saline rinses
    Intervention: Other: Normal Saline
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 7, 2014)
72
Original Estimated Enrollment  ICMJE
 (submitted: November 2, 2011)
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:

  • 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
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
Principal Investigator: Andreas Charalambous, PhD Cyprus University of Technology
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