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Completed

NCT Number: NCT01465308

The Effect of Honey on Xerostomia and Oral Mucositis

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)

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Key information

Conditions

Head and Neck Cancer Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Bank of Cyprus Oncology Centre

Nicosia, 2006, Cyprus

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Normal Saline

Other

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

Primary outcomes

  1. Change from baseline in Xerostomia grades

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

  2. Change from baseline in oral mucositis grades

    Time frame: 1 week, 2 weeks, 3 weeks, 4 weeks

Secondary outcomes

  1. Changes in the General satisfaction of comfort

    Time frame: 1 week, 2 week, 3 week, 4 week

  2. Change in baseline weight in one month

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

Cyprus University of Technology

Other

Registry information

Official study title

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

Acronym: AC-H

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Nov 4, 2011
Registry last updated
Oct 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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