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

February 4, 2008
May 22, 2012
July 2008
October 2011   (final data collection date for primary outcome measure)
Severity of mucositis according to OMAS scale [ Time Frame: Over 7 weeks of expected duration of mucositis ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00615420 on ClinicalTrials.gov Archive Site
Percentage weight loss [ Time Frame: From day one of radiation to last day of week following completion of radiation ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer
A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Supportive Care
  • Radiotherapy Induced Mucositis
  • Head and Neck Cancer
  • 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.
  • 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.
  • Experimental: 1
    Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed
    Intervention: Dietary Supplement: manuka honey
  • Placebo Comparator: 2
    Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed
    Intervention: Dietary Supplement: placebo gel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00615420
H07-02297, H07-02297
No
British Columbia Cancer Agency
British Columbia Cancer Agency
Not Provided
Principal Investigator: Philippa Hawley, B.Med British Columbia Cancer Agency
British Columbia Cancer Agency
May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP