The Effect of Honey on Xerostomia and Oral Mucositis

Phase 2

Completed

• Conditions: Head and Neck Cancer
• Interventions: Other: Normal Saline; Dietary Supplement: Honey mouthwash

• Registration Number: NCT01465308
• Lead Sponsor: Cyprus University of Technology

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 Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-10-31
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-04
• Primary Completion: 2014-09
• Status Verified: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-07
• Last Update Posted: 2014-10-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Saline mouthwash	Normal Saline	The patients in this group will receive saline rinses
receiving Honey	Honey mouthwash	The patients will receive honey mouthwash rinses

Primary Outcome Measures

Name	Time	Method
Change from baseline in Xerostomia grades	1 week, 2 weeks, 3 weeks, 4 weeks
Change from baseline in oral mucositis grades	1 week, 2 weeks, 3 weeks, 4 weeks

Secondary Outcome Measures

Name	Time	Method
Changes in the General satisfaction of comfort	1 week, 2 week, 3 week, 4 week
Change in baseline weight in one month	4 weeks

Trial Locations

Locations (1)

Bank of Cyprus Oncology Centre; 🇨🇾 Nicosia, Cyprus