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Sponsored by: |
British Columbia Cancer Agency |
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Information provided by: | British Columbia Cancer Agency |
ClinicalTrials.gov Identifier: | NCT00615420 |
The primary hypothesis of this study is that regular topical oral application of Manuka Honey will reduce the severity and duration of oral mucositis in patients who are undergoing mucotoxic radiation therapy for cancer treatment.
Condition | Intervention | Phase |
---|---|---|
Radiotherapy Induced Mucositis Head and Neck Cancer |
Dietary Supplement: manuka honey Dietary Supplement: placebo gel |
Phase III |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer |
Estimated Enrollment: | 200 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | August 2010 |
Estimated Primary Completion Date: | August 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed
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Dietary Supplement: manuka honey
Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed
|
2: Placebo Comparator
Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed
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Dietary Supplement: placebo gel
Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed
|
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Philippa Hawley, B.Med | 604-877-6000 ext 2707 | phawley@bccancer.bc.ca |
Contact: Allan Hovan, Dentist | 604-877-6000 ext 4551 | ahovan@bccancer.bc.ca |
Canada, British Columbia | |
BC Cancer Agency | Recruiting |
Vancouver, British Columbia, Canada, V5Z 4E6 | |
Sub-Investigator: Allan Hovan, Dentist | |
BC Cancer Agency | Not yet recruiting |
Surrey, British Columbia, Canada |
Principal Investigator: | Philippa Hawley, B.Med | BC Cancer Agency |
Responsible Party: | BC Cancer Agency ( Philippa Hawley ) |
Study ID Numbers: | H07-02297, H07-02297 |
Study First Received: | February 4, 2008 |
Last Updated: | August 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00615420 |
Health Authority: | Canada: Ethics Review Committee |
Mucositis Radiation Honey |
Mouth Diseases Digestive System Diseases Stomatitis Mucositis |
Gastrointestinal Diseases Head and Neck Neoplasms Stomatognathic Diseases Gastroenteritis |
Neoplasms Neoplasms by Site |