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Trial record 21 of 1120 for:    Oral Cancer | ( Map: Canada )

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

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ClinicalTrials.gov Identifier: NCT00615420
Recruitment Status : Completed
First Posted : February 14, 2008
Results First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
British Columbia Cancer Agency

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Supportive Care
Conditions Radiotherapy Induced Mucositis
Head and Neck Cancer
Interventions Dietary Supplement: manuka honey
Dietary Supplement: placebo gel
Enrollment 106
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Honey Placebo
Hide Arm/Group Description

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

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.

Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed

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.

Period Title: Overall Study
Started 54 52
Completed 23 25
Not Completed 31 27
Arm/Group Title Honey Placebo Total
Hide Arm/Group Description

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

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.

Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed

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.

Total of all reporting groups
Overall Number of Baseline Participants 54 52 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 52 participants 48 participants 100 participants
56.8
(32 to 100)
59.5
(41 to 85)
58.1
(32 to 100)
[1]
Measure Analysis Population Description: Not all patients have baseline information available
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 50 participants 104 participants
Female
10
  18.5%
8
  16.0%
18
  17.3%
Male
44
  81.5%
42
  84.0%
86
  82.7%
[1]
Measure Analysis Population Description: Not all patients have baseline information available
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
Weight   [1] 
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 52 participants 50 participants 102 participants
85.6  (19.3) 79.6  (15.2) 82.7  (17.6)
[1]
Measure Analysis Population Description: Not all patients have baseline information available
Diabetic  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 52 participants 106 participants
3
   5.6%
10
  19.2%
13
  12.3%
Smoker  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 52 participants 106 participants
9
  16.7%
7
  13.5%
16
  15.1%
ECOG > 0  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 52 participants 106 participants
8
  14.8%
13
  25.0%
21
  19.8%
Chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 52 participants 106 participants
31
  57.4%
35
  67.3%
66
  62.3%
Radiation Therapy => 7,000 Gy   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 54 participants 52 participants 106 participants
36
  66.7%
30
  57.7%
66
  62.3%
[1]
Measure Description: Gy = Gray; the international system unit of radiation dose
1.Primary Outcome
Title Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment
Hide Description 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.
Time Frame Over 7 weeks of expected duration of mucositis
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had at least one mucositis assessment were included in this analysis
Arm/Group Title Honey Placebo
Hide Arm/Group Description:

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

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.

Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed

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.

Overall Number of Participants Analyzed 40 41
Measure Type: Count of Participants
Unit of Measure: Participants
14
  35.0%
18
  43.9%
2.Primary Outcome
Title Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had a Minimum of 2 Mucositis Assessments
Hide Description 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.
Time Frame Over 7 weeks of expected duration of mucositis
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who had a minimum of 2 mucositis assessments were included in this analysis
Arm/Group Title Honey Placebo
Hide Arm/Group Description:

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

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.

Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed

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.

Overall Number of Participants Analyzed 31 33
Measure Type: Count of Participants
Unit of Measure: Participants
11
  35.5%
16
  48.5%
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Honey Placebo
Hide Arm/Group Description

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

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.

Sugar-free placebo gel 5ml 4 times a day, swished and held in mouth for 30 secs then swallowed

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.

All-Cause Mortality
Honey Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/52 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Honey Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/54 (0.00%)   0/52 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Honey Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   8/54 (14.81%)   6/52 (11.54%) 
Gastrointestinal disorders     
Nausea  8/54 (14.81%)  5/52 (9.62%) 
Product Issues     
Bad Taste  0/54 (0.00%)  1/52 (1.92%) 
Burning Sensation in Mouth  2/54 (3.70%)  0/52 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Philippa Hawley
Organization: BC Cancer
Phone: (604) 877-6000 ext 67-2752
Responsible Party: British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT00615420     History of Changes
Other Study ID Numbers: H07-02297
H07-02297
First Submitted: February 4, 2008
First Posted: February 14, 2008
Results First Submitted: October 19, 2018
Results First Posted: June 5, 2019
Last Update Posted: June 5, 2019