The Effect of Honey on Xerostomia and Oral Mucositis

NCT01465308 | Completed Phase 2

• 1 other identifier: AC-HANHS-86
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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)

Conditions

Head and Neck Cancer

Keywords

head and neck cancer; radiotherapy induced xerostomia; radiotherapy induced oral mucositis; RCT; symptom management

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Changes in the General satisfaction of comfort

  1 week, 2 week, 3 week, 4 week

• Change in baseline weight in one month

  4 weeks

Study Arms (2)

receiving Honey

EXPERIMENTAL

The patients will receive honey mouthwash rinses

Dietary Supplement: Honey mouthwash

Saline mouthwash

ACTIVE COMPARATOR

The patients in this group will receive saline rinses

Other: Normal Saline

Interventions

Honey mouthwash DIETARY_SUPPLEMENT

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

receiving Honey

Normal Saline OTHER

Saline rinses 15 minutes before radiotherapy, 15 minutes after, and 6 hours after radiotherapy

Saline mouthwash

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Allergic to honey
• confirmed and medically treated diabetes mellitus

Sponsors & Collaborators

• Cyprus University of Technology: lead

Study Sites (1)

Bank of Cyprus Oncology Centre

Nicosia, Nicosia, 2006, Cyprus

Location

Related Publications (2)

• Charalambous M, Raftopoulos V, Paikousis L, Katodritis N, Lambrinou E, Vomvas D, Georgiou M, Charalambous A. The effect of the use of thyme honey in minimizing radiation - induced oral mucositis in head and neck cancer patients: A randomized controlled trial. Eur J Oncol Nurs. 2018 Jun;34:89-97. doi: 10.1016/j.ejon.2018.04.003. Epub 2018 Apr 30.

  PMID: 29784145 DERIVED

• Charalambous A, Lambrinou E, Katodritis N, Vomvas D, Raftopoulos V, Georgiou M, Paikousis L, Charalambous M. The effectiveness of thyme honey for the management of treatment-induced xerostomia in head and neck cancer patients: A feasibility randomized control trial. Eur J Oncol Nurs. 2017 Apr;27:1-8. doi: 10.1016/j.ejon.2017.01.001. Epub 2017 Jan 16.

  PMID: 28279391 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Andreas Charalambous, PhD

  Cyprus University of Technology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer-Researcher

Study Record Dates

• First Submitted: October 31, 2011
• First Posted: November 4, 2011
• Study Start: August 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 8, 2014

Record last verified: 2014-10

Locations

CY (1)