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

Sponsored by:	British Columbia Cancer Agency
Information provided by:	British Columbia Cancer Agency
ClinicalTrials.gov Identifier:	NCT00615420

Purpose

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

MedlinePlus related topics: Cancer Dietary Supplements Head and Neck Cancer

U.S. FDA Resources

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

Further study details as provided by British Columbia Cancer Agency:

Primary Outcome Measures:

Severity of mucositis according to OMAS scale [ Time Frame: Over 7 weeks of expected duration of mucositis ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Percentage weight loss [ Time Frame: From day one of radiation to last day of week following completion of radiation ] [ Designated as safety issue: No ]

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	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	Dietary Supplement: placebo gel Sugar-free honey-flavoured gel 5ml 4 times a day swished and held in mouth for 30 secs then swallowed

Detailed Description:

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.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients commencing radiation therapy of 50 Gy or higher with the dosage field affecting the oral mucosa unilaterally or bilaterally (minimum 3 observable sites affected).
Patients willing and able to attend weekly assessments throughout their treatment, plus one week after completion of treatment.

Exclusion Criteria:

Patients unable to understand the consent process (translators will be used if necessary so being English-speaking is not required).
Patients unable to attend the follow-up visits
Patients participating in other clinical trials which might affect the severity of mucositis
Patients allergic to honey, multiple pollens, or to celery

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00615420

Contacts

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

Locations

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

Sponsors and Collaborators

British Columbia Cancer Agency

Investigators

Principal Investigator:

Philippa Hawley, B.Med

BC Cancer Agency

More Information

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

Keywords provided by British Columbia Cancer Agency:

Mucositis
Radiation
Honey

Study placed in the following topic categories:

Mouth Diseases
Digestive System Diseases
Stomatitis
Mucositis

Gastrointestinal Diseases
Head and Neck Neoplasms
Stomatognathic Diseases
Gastroenteritis

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 14, 2009