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

• ClinicalTrials.gov Identifier: NCT01465308
• Recruitment Status: Completed
• First Posted: November 4, 2011
• Last Update Posted: October 8, 2014
• Sponsor: Cyprus University of Technology
• Information provided by (Responsible Party): Dr. Andreas Charalambous, Cyprus University of Technology

Tracking Information

• First Submitted Date: October 31, 2011
• First Posted Date: November 4, 2011
• Last Update Posted Date: October 8, 2014
• Study Start Date: August 2011
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: November 2, 2011)

• Change from baseline in Xerostomia grades [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ]
• Change from baseline in oral mucositis grades [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ]

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: November 2, 2011)

• Changes in the General satisfaction of comfort [ Time Frame: 1 week, 2 week, 3 week, 4 week ]
• Change in baseline weight in one month [ Time Frame: 4 weeks ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Honey on Xerostomia and Oral Mucositis
• 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
• 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 Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Investigator); Primary Purpose: Treatment
• Condition: Head and Neck Cancer

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

Study Arms

• Experimental: receiving Honey
  The patients will receive honey mouthwash rinses
  Intervention: Dietary Supplement: Honey mouthwash
• Active Comparator: Saline mouthwash
  The patients in this group will receive saline rinses
  Intervention: Other: Normal Saline

Publications *

• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 7, 2014): 72
• Original Estimated Enrollment (submitted: November 2, 2011): 40
• Actual Study Completion Date: October 2014
• Actual Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 70 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Cyprus

Administrative Information

• NCT Number: NCT01465308
• Other Study ID Numbers: AC-HANHS-86
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Andreas Charalambous, Cyprus University of Technology
• Study Sponsor: Cyprus University of Technology
• Collaborators: Not Provided

Investigators

• Principal Investigator: Andreas Charalambous, PhD; Cyprus University of Technology

• PRS Account: Cyprus University of Technology
• Verification Date: October 2014