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

Primary Purpose

Head and Neck Cancer

Status
Completed
Phase
Phase 2
Locations
Cyprus
Study Type
Interventional
Intervention
Honey mouthwash
Normal Saline
Sponsored by
Cyprus University of Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring head and neck cancer, radiotherapy induced xerostomia, radiotherapy induced oral mucositis, RCT, symptom management

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Bank of Cyprus Oncology Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

receiving Honey

Saline mouthwash

Arm Description

The patients will receive honey mouthwash rinses

The patients in this group will receive saline rinses

Outcomes

Primary Outcome Measures

Change from baseline in Xerostomia grades
Change from baseline in oral mucositis grades

Secondary Outcome Measures

Changes in the General satisfaction of comfort
Change in baseline weight in one month

Full Information

First Posted
October 31, 2011
Last Updated
October 7, 2014
Sponsor
Cyprus University of Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01465308
Brief Title
The Effect of Honey on Xerostomia and Oral Mucositis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cyprus University of Technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
Keywords
head and neck cancer, radiotherapy induced xerostomia, radiotherapy induced oral mucositis, RCT, symptom management

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
receiving Honey
Arm Type
Experimental
Arm Description
The patients will receive honey mouthwash rinses
Arm Title
Saline mouthwash
Arm Type
Active Comparator
Arm Description
The patients in this group will receive saline rinses
Intervention Type
Dietary Supplement
Intervention Name(s)
Honey mouthwash
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Normal Saline
Intervention Description
Saline rinses 15 minutes before radiotherapy, 15 minutes after, and 6 hours after radiotherapy
Primary Outcome Measure Information:
Title
Change from baseline in Xerostomia grades
Time Frame
1 week, 2 weeks, 3 weeks, 4 weeks
Title
Change from baseline in oral mucositis grades
Time Frame
1 week, 2 weeks, 3 weeks, 4 weeks
Secondary Outcome Measure Information:
Title
Changes in the General satisfaction of comfort
Time Frame
1 week, 2 week, 3 week, 4 week
Title
Change in baseline weight in one month
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andreas Charalambous, PhD
Organizational Affiliation
Cyprus University of Technology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bank of Cyprus Oncology Centre
City
Nicosia
ZIP/Postal Code
2006
Country
Cyprus

12. IPD Sharing Statement

Citations:
PubMed Identifier
29784145
Citation
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.
Results Reference
derived
PubMed Identifier
28279391
Citation
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.
Results Reference
derived

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The Effect of Honey on Xerostomia and Oral Mucositis

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