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

NCT00615420 | Completed Phase 3 Results

• 1 other identifier: H07-02297
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Radiotherapy Induced Mucositis; Head and Neck Cancer

Keywords

Mucositis; Radiation; Honey

Outcome Measures

Primary Outcomes (2)

• Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment

  Worst Radiation Therapy Oncology Group (RTOG) score greater than or equal to Grade 3 mucositis The scale ranges from Grade 0 (No mucositis) to Grade 4 (Necrosis or deep ulceration ± bleeding) where Grade 0 is the best outcome and Grade 4 is the worst outcome.

  Over 7 weeks of expected duration of mucositis

• Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had a Minimum of 2 Mucositis Assessments

  Worst Radiation Therapy Oncology Group (RTOG) score greater than or equal to Grade 3 mucositis The scale ranges from Grade 0 (No mucositis) to Grade 4 (Necrosis or deep ulceration ± bleeding) where Grade 0 is the best outcome and Grade 4 is the worst outcome.

  Over 7 weeks of expected duration of mucositis

Study Arms (2)

Manuka Honey

EXPERIMENTAL

Irradiated organic manuka honey 5ml 4 times a day held in mouth for 30 secs then swallowed

Dietary Supplement: manuka honey

Placebo

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

Interventions

manuka honey DIETARY_SUPPLEMENT

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.

Manuka Honey

placebo gel DIETARY_SUPPLEMENT

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.

Placebo

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• British Columbia Cancer Agency: lead

Study Sites (2)

BC Cancer Agency

Surrey, British Columbia, Canada

Location

BC Cancer Agency

Vancouver, British Columbia, V5Z 4E6, Canada

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Mucositis

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Mouth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. Philippa Hawley
• Organization: BC Cancer

phawley@bccancer.bc.ca

(604) 877-6000

Study Officials

• Philippa Hawley, B.Med

  British Columbia Cancer Agency

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study was blinded to all except necessary pharmacy staff until after the study was closed.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2008
• First Posted: February 14, 2008
• Study Start: July 1, 2008
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: June 5, 2019
• Results First Posted: June 5, 2019

Record last verified: 2012-05

Locations

CA (2)