The Effect of Honey on Xerostomia and Oral Mucositis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Study Completion Date

2014-10-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Head and Neck Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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receiving Honey

The patients will receive honey mouthwash rinses

Group Type EXPERIMENTAL

Honey mouthwash

Intervention Type 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

Saline mouthwash

The patients in this group will receive saline rinses

Group Type ACTIVE_COMPARATOR

Normal Saline

Intervention Type OTHER

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

Interventions

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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

Intervention Type DIETARY_SUPPLEMENT

Normal Saline

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

Intervention Type OTHER

Eligibility Criteria

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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