TerminatedPhase 2ACTRN12609000012279

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


Sponsor

University of Otago

Enrollment

120 participants

Start Date

Mar 4, 2009

Study Type

Interventional

Conditions

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.


Eligibility

Sex: Both males and females

Plain Language Summary

Simplified for easier understanding

This study is for patients of any age with head and neck cancer whose radiation treatment will deliver a significant dose to the mouth area. It tests whether Manuka honey can help prevent or reduce mouth sores (oral mucositis) caused by radiation therapy. Participants apply the honey as directed during their radiation treatment.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

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).


Locations(1)

Wellington, Palmerston North and Dunedin, New Zealand

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ACTRN12609000012279


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