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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT00615420
First received: February 4, 2008
Last updated: May 22, 2012
Last verified: May 2012
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Supportive Care
Official Title: A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer

Resource links provided by NLM:


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 ]

Enrollment: 106
Study Start Date: July 2008
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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.

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

Locations
Canada, British Columbia
BC Cancer Agency
Surrey, British Columbia, Canada
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
British Columbia Cancer Agency
Investigators
Principal Investigator: Philippa Hawley, B.Med British Columbia Cancer Agency
  More Information

No publications provided

Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00615420     History of Changes
Other Study ID Numbers: H07-02297, H07-02297
Study First Received: February 4, 2008
Last Updated: May 22, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by British Columbia Cancer Agency:
Mucositis
Radiation
Honey

Additional relevant MeSH terms:
Head and Neck Neoplasms
Stomatitis
Mucositis
Neoplasms by Site
Neoplasms
Mouth Diseases
Stomatognathic Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 20, 2014