A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
|ClinicalTrials.gov Identifier: NCT00615420|
Recruitment Status : Completed
First Posted : February 14, 2008
Last Update Posted : May 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Radiotherapy Induced Mucositis Head and Neck Cancer||Dietary Supplement: manuka honey Dietary Supplement: placebo gel||Phase 3|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||106 participants|
|Intervention Model:||Parallel Assignment|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||October 2011|
|Actual Study Completion Date :||October 2011|
Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed
Dietary Supplement: manuka honey
Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.
Placebo Comparator: 2
Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed
Dietary Supplement: placebo gel
Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed. May be diluted with equal or twice the volume of water to reduce nausea in patients already nauseated from chemotherapy.
- Severity of mucositis according to OMAS scale [ Time Frame: Over 7 weeks of expected duration of mucositis ]
- Percentage weight loss [ Time Frame: From day one of radiation to last day of week following completion of radiation ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00615420
|Canada, British Columbia|
|BC Cancer Agency|
|Surrey, British Columbia, Canada|
|BC Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Principal Investigator:||Philippa Hawley, B.Med||British Columbia Cancer Agency|