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

This study is currently recruiting participants.
Verified January 2013 by Cyprus University of Technology
Sponsor:
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology
ClinicalTrials.gov Identifier:
NCT01465308
First received: October 31, 2011
Last updated: January 8, 2013
Last verified: January 2013

October 31, 2011
January 8, 2013
August 2011
January 2013   (final data collection date for primary outcome measure)
  • Change from baseline in Xerostomia grades [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in oral mucositis grades [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01465308 on ClinicalTrials.gov Archive Site
  • Changes in the General satisfaction of comfort [ Time Frame: 1 week, 2 week, 3 week, 4 week ] [ Designated as safety issue: No ]
  • Change in baseline weight in one month [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
The Effect of Honey on Xerostomia and Oral Mucositis
A Randomized Control Trial for the Effect of Honey on Radiotherapy Induced Xerostomia and Oral Mucositis in Patients With Head and Neck Cancers

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)

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Head and Neck Cancer
  • 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
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Melanie Charalambous, PhDc 0035799514855 melanie.charalambous@cut.ac.cy
Cyprus
 
NCT01465308
AC-HANHS-86
No
Dr. Andreas Charalambous, Cyprus University of Technology
Cyprus University of Technology
Not Provided
Principal Investigator: Andreas Charalambous, PhD Cyprus University of Technology
Cyprus University of Technology
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP