The Effect of Honey on Xerostomia and Oral Mucositis

Head and Neck Cancer Clinical Trial

— AC-H  

Official title:

A Randomized Control Trial for the Effect of Honey on Radiotherapy Induced Xerostomia and Oral Mucositis in Patients With Head and Neck Cancers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465308
• Other study ID #: AC-HANHS-86
• Status: Completed
• Phase: Phase 2
• First received: October 31, 2011
• Last updated: October 7, 2014
• Start date: August 2011
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Cyprus University of Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cyprus: Ministry of Health
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms
• Mucositis
• Stomatitis
• Xerostomia

Intervention

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

Locations

Country	Name	City	State
Cyprus	Bank of Cyprus Oncology Centre	Nicosia

Sponsors (1)

Lead Sponsor	Collaborator
Cyprus University of Technology

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Xerostomia grades		1 week, 2 weeks, 3 weeks, 4 weeks	No
Primary	Change from baseline in oral mucositis grades		1 week, 2 weeks, 3 weeks, 4 weeks	No
Secondary	Changes in the General satisfaction of comfort		1 week, 2 week, 3 week, 4 week	No
Secondary	Change in baseline weight in one month		4 weeks	No