Trial Information

A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer

Oral mucositis is a common side-effect of radiation therapy for many head and neck cancers,
and can have a very severe impact on quality of life and nutritional status. At least42% of
patients treated for head and neck cancers will develop grade 3 or 4 oral mucositis.
Although there have been positive trials, no study has had overwhelming data to strongly
support any one agent in the prevention or treatment of oral mucositis. A comprehensive
review of the literature done in 2004 found only benzydamine (a topical nonsteroidal
anti-inflammatory agent) to be beneficial as a palliative treatment for established
mucositis. Management essentially consists of pain management, with topical and oral
analgesics/anaesthetics and anti-inflammatory agents, and nutritional support, once
mucositis is established. Despite the use of these agents, many patients still have severe
mucositis, and there is great need for new treatments to reduce this distressing
complication of cancer therapy.

Currently, the only standard "treatment" consists of an oral rinse of warm water, salt, and
baking soda 4 times a day. This is only to maintain oral hygiene and does not have any
impact on the severity or duration of the mucositis itself. Topical fluoride is applied at
bedtime to reduce the caries risk. Basic oral care (brushing and flossing as tolerated) is
recommended to maintain general mucosal health and to reduce the impact of oral microbial
flora.

Study Objectives The primary objective of this study is to see if topical oral Manuka honey
reduces the severity of mucositis in patients receiving radiation treatment for head and
neck cancer. Secondary objectives are to assess the impact of any demonstrated improvement
in mucositis on nutrition, symptom burden, quality of life, and radiotherapy treatment
interruptions.