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Trial registered on ANZCTR


Registration number
ACTRN12609000012279
Ethics application status
Approved
Date submitted
11/11/2008
Date registered
8/01/2009
Date last updated
25/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
The Effect of Manuka Honey on Oral Mucositis
Scientific title
The Effect of Comvita Manuka Honey on the Extent of Oral Mucositis in 120 Patients treated with Radiation Therapy for Head and Neck malignancies
Secondary ID [1] 746 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Oral Mucositis 3963 0
Condition category
Condition code
Oral and Gastrointestinal 4159 4159 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants randomized to the Honey arm of the trial will receive best practice of care, and in addition, swirl 20 mL of pure Comvita Manuka Honey in their mouth to coat the oral cavity three times a day from the moment they start radiation therapy treatment till 4 weeks after completion of treatment (end of the trial).
Intervention code [1] 3682 0
Treatment: Other
Comparator / control treatment
Participants randomized to the control group receive best practice of care. This will vary for the different centres from using a dilute bicarbonate soda mouthwash, dilute salt mouth washes to difflam or oral balance. Different radiation oncologists will recommend different options. All of these will be considered best practice of care. All will recommend good oral hygiene, using a soft tooth brush, a fluoride tooth paste, avoiding hot spicey foods, alcohol and tobacco.
Control group
Active

Outcomes
Primary outcome [1] 5057 0
Total mucositis scores. Mucositis scores will be done using a validated scoring system (Epstein et al., 2001). Basically the oral cavity will be divided into 14 anatomical sites and each site is scored 0-4 (O: no change, 1: erythema<50% of area, 2: erythema >50% of area, 3: single ulcer<1cm, 4: multiple ulcers or single ulcer>1cm). Scoring will be done by a radiation therapist who will have received appropriate training for this.
Timepoint [1] 5057 0
Mucositis scores will be done 3 times a week during the entire radiation therapy (RT) treatment. After completion of treatment 2 more assessments will be done: at 2 and 4 weeks after completion of radiation therapy (RT) treatment
Secondary outcome [1] 8505 0
Dose/time to first sign of oral mucositis. This will be measured as the dose that has resulted in the first sign of mucositis as determined by the mucositis scoring system explained previously.
Timepoint [1] 8505 0
Mucositis will be scored as for key primary outcome three times a week for the duration of RT treatment; we expect to see the dose accumulation reaching measurable levels of mucositis 1-2 weeks after starting radiation therapy (RT) treatment
Secondary outcome [2] 8507 0
Weight measurements will be done using the same weight scales in the hospital department
Timepoint [2] 8507 0
Weight will be measured before start of the trial, weekly during the trial and at the completion of the trial.
Secondary outcome [3] 8508 0
Quality of Life, using validated QOL questionnaires (EORTC QLQ-C30 (version 3) and the EORTC QLQ-H&N35)
Timepoint [3] 8508 0
QOL will be measured before start of the trial, fortnightly during the trial and at the completion of the trial.
Secondary outcome [4] 8509 0
Composition of oral microflora. This will be assessed by DNA/DNA hybridization checkerboard techniques.
Timepoint [4] 8509 0
Oral flora composition will be measured by taking small micro swabs of the ventral surface of the tongue, before RT treatment, 3 weeks after start of RT treatment, at completion of RT treatment and 4 weeks after completion of RT treatment

Eligibility
Key inclusion criteria
Patients with head and neck malignancies whose radiation therapy treatment (based on treatment plans) delivers a minimum of 4000cGy to at least 2 anatomical locations in the oral cavity.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Previous radiation therapy,
2. Presence of systemic disease,
3. Diabetes,
4. Allergy to honey.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Contacting the holder of the randomization schedule who is the Principal Investigator (PI) of the study but not involved with any of the patients at any time and who is off site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation based on the expected severity of the oral mucositis, based on treatment plans. All treatment plans will be faxed to the PI who will allocate the patient to three groups (oral mucositis is mild, moderate or severe) and randomize patient to either honey or control arm, with these groups, using an appropriate computer programme.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
none
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Date of first participant enrolment
Anticipated
1/03/2009
Actual
4/03/2009
Date of last participant enrolment
Anticipated
1/03/2011
Actual
15/02/2010
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
28
Recruitment outside Australia
Country [1] 1368 0
New Zealand
State/province [1] 1368 0
Wellington, Palmerston North and Dunedin

Funding & Sponsors
Funding source category [1] 4148 0
University
Name [1] 4148 0
University of Otago
Country [1] 4148 0
New Zealand
Funding source category [2] 4149 0
Hospital
Name [2] 4149 0
Otago Distric Health Board
Country [2] 4149 0
New Zealand
Funding source category [3] 4150 0
Hospital
Name [3] 4150 0
MidCentral Distric Health Board
Country [3] 4150 0
New Zealand
Funding source category [4] 4151 0
Hospital
Name [4] 4151 0
Capital & Coast Distric Health Board
Country [4] 4151 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
PO Box 56
Dunedin, 9054
Country
New Zealand
Secondary sponsor category [1] 3732 0
Hospital
Name [1] 3732 0
Otago Distric Health Board
Address [1] 3732 0
Department of Oncology
Dundin Hospital
PO Box 1921
Dunedin 9016
Country [1] 3732 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6215 0
Multiregion Ethics Committee
Ethics committee address [1] 6215 0
Ministry of Health
PO Box 5013
Wellington
Ethics committee country [1] 6215 0
New Zealand
Date submitted for ethics approval [1] 6215 0
25/10/2008
Approval date [1] 6215 0
17/12/2008
Ethics approval number [1] 6215 0

Summary
Brief summary
Radiation therapy to the head and neck aims to eradicate tumour cells and, in addition, can damage the lining of the mouth, varying from reddening to blistering and ulceration (oral mucositis). Although these reactions are temporary and are usually resolved over time, they can affect patients’ ability to eat, drink and talk, compromising their quality of life. In extreme cases, radiation treatment has to be postponed, jeopardizing tumour control and survival. There is currently no standard treatment for oral mucositis. Recently three small clinical trials have suggested that honey reduces the extent of oral mucositis in head and neck patients.
The proposed trial aims to test these claims in 120 head and neck patients, randomized to either treatment or control group. The treatment group will use Comvita Manuka Honey three times a day throughout the trial, whilst the control group will use a standard bicarbonate soda mouthwash three times a day. The extent of mucositis will be assessed three times a week in all patients during treatment, and 2 and 4 weeks after completion of treatment. Weight will be assessed weekly and quality of life forthnightly during treatment, and 2 and 4 weeks after treatment completion.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29119 0
Dr Herst
Address 29119 0
POBox 7343
Wellington South
Postcode 6242
New Zealand
Country 29119 0
New Zealand
Phone 29119 0
+64-4-3855475
Fax 29119 0
Email 29119 0
[email protected]
Contact person for public queries
Name 12276 0
Dr Patries Herst
Address 12276 0
Department of Radiation Therapy
University of Otago, Wellington
PO Box 7343,
Wellington South 6242
Country 12276 0
New Zealand
Phone 12276 0
+64 4 3855475
Fax 12276 0
+64 4 3855375
Email 12276 0
[email protected]
Contact person for scientific queries
Name 3204 0
Dr Patries Herst
Address 3204 0
Department of Radiation Therapy
University of Otago, Wellington
PO Box 7343,
Wellington South 6242
Country 3204 0
New Zealand
Phone 3204 0
+64 4 3855475
Fax 3204 0
+64 4 3855375
Email 3204 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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