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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr. Andreas Charalambous, Cyprus University of Technology
ClinicalTrials.gov Identifier:
NCT01465308
First received: October 31, 2011
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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)


Condition Intervention Phase
Head and Neck Cancer
Dietary Supplement: Honey mouthwash
Other: Normal Saline
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Cyprus University of Technology:

Primary Outcome Measures:
  • Change from baseline in Xerostomia grades [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in oral mucositis grades [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes in the General satisfaction of comfort [ Time Frame: 1 week, 2 week, 3 week, 4 week ] [ Designated as safety issue: No ]
  • Change in baseline weight in one month [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 72
Study Start Date: August 2011
Study Completion Date: October 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01465308

Locations
Cyprus
Bank of Cyprus Oncology Centre
Nicosia, Cyprus, 2006
Sponsors and Collaborators
Cyprus University of Technology
Investigators
Principal Investigator: Andreas Charalambous, PhD Cyprus University of Technology
  More Information

No publications provided

Responsible Party: Dr. Andreas Charalambous, Lecturer-Researcher, Cyprus University of Technology
ClinicalTrials.gov Identifier: NCT01465308     History of Changes
Other Study ID Numbers: AC-HANHS-86
Study First Received: October 31, 2011
Last Updated: October 7, 2014
Health Authority: Cyprus: Ministry of Health

Keywords provided by Cyprus University of Technology:
head and neck cancer
radiotherapy induced xerostomia
radiotherapy induced oral mucositis
RCT
symptom management

Additional relevant MeSH terms:
Head and Neck Neoplasms
Mucositis
Stomatitis
Xerostomia
Neoplasms by Site
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Salivary Gland Diseases

ClinicalTrials.gov processed this record on October 16, 2014