The Effect of Manuka Honey on Oral Mucositis

The Effect of Comvita Manuka Honey on the Extent of Oral Mucositis in 120 Patients treated with Radiation Therapy for Head and Neck malignancies

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12609000012279

Enrollment

Registered

2009-01-08

Start date

2009-03-04

Completion date

2010-02-15

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Radiation therapy to the head and neck aims to eradicate tumour cells and, in addition, can damage the lining of the mouth, varying from reddening to blistering and ulceration (oral mucositis). Although these reactions are temporary and are usually resolved over time, they can affect patients’ ability to eat, drink and talk, compromising their quality of life. In extreme cases, radiation treatment has to be postponed, jeopardizing tumour control and survival. There is currently no standard treatment for oral mucositis. Recently three small clinical trials have suggested that honey reduces the extent of oral mucositis in head and neck patients. The proposed trial aims to test these claims in 120 head and neck patients, randomized to either treatment or control group. The treatment group will use Comvita Manuka Honey three times a day throughout the trial, whilst the control group will use a standard bicarbonate soda mouthwash three times a day. The extent of mucositis will be assessed three times a week in all patients during treatment, and 2 and 4 weeks after completion of treatment. Weight will be assessed weekly and quality of life forthnightly during treatment, and 2 and 4 weeks after treatment completion.

Interventions

Participants randomized to the Honey arm of the trial will receive best practice of care, and in addition, swirl 20 mL of pure Comvita Manuka Honey in their mouth to coat the oral cavity three times a day from the moment they start radiation therapy treatment till 4 weeks after completion of treatment (end of the trial).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

0 to No maximum

Healthy volunteers

Inclusion criteria

Patients with head and neck malignancies whose radiation therapy treatment (based on treatment plans) delivers a minimum of 4000cGy to at least 2 anatomical locations in the oral cavity.

Exclusion criteria

1. Previous radiation therapy, 2. Presence of systemic disease, 3. Diabetes, 4. Allergy to honey.

Outcome results