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

Cyprus University of Technology

Status and phase: Completed; Phase 2

Conditions: Head and Neck Cancer

Treatments: Dietary Supplement: Honey mouthwash; Other: Normal Saline

Study type: Interventional

Funder types: Other

Identifiers

NCT01465308

AC-HANHS-86

Details and patient eligibility

About

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)

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

receiving Honey

Experimental group

Description:

The patients will receive honey mouthwash rinses

Treatment:

Dietary Supplement: Honey mouthwash

Saline mouthwash

Active Comparator group

Description:

The patients in this group will receive saline rinses

Treatment:

Other: Normal Saline