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

October 7, 2014 updated by: Dr. Andreas Charalambous, Cyprus University of Technology

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

72

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cyprus
      • Nicosia, Cyprus, 2006
        • Bank Of Cyprus Oncology Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: receiving Honey
The patients will receive honey mouthwash rinses
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
Active Comparator: Saline mouthwash
The patients in this group will receive saline rinses
Other: Normal Saline
Saline rinses 15 minutes before radiotherapy, 15 minutes after, and 6 hours after radiotherapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in Xerostomia grades
Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks
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
1 week, 2 weeks, 3 weeks, 4 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in the General satisfaction of comfort
Time Frame: 1 week, 2 week, 3 week, 4 week
1 week, 2 week, 3 week, 4 week
Change in baseline weight in one month
Time Frame: 4 weeks
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyprus University of Technology

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

October 31, 2011

First Submitted That Met QC Criteria

November 2, 2011

First Posted (Estimate)

November 4, 2011

Study Record Updates

Last Update Posted (Estimate)

October 8, 2014

Last Update Submitted That Met QC Criteria

October 7, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-HANHS-86

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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