Trial Outcomes & Findings for A Randomized Placebo-Controlled Trial of Manuka Honey for Oral Mucositis Due to Radiation Therapy for Cancer (NCT NCT00615420)

Last Updated: 2019-06-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

106 participants

Primary outcome timeframe

Over 7 weeks of expected duration of mucositis

Results posted on

2019-06-05

Participant Flow

Participant milestones

Participant milestones
Measure	Honey 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.	Placebo 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 Study STARTED	54	52
Overall Study COMPLETED	23	25
Overall Study NOT COMPLETED	31	27

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Not all patients have baseline information available

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Honey n=54 Participants 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.	Placebo n=52 Participants 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 n=106 Participants Total of all reporting groups
Age, Continuous	56.8 years n=52 Participants • Not all patients have baseline information available	59.5 years n=48 Participants • Not all patients have baseline information available	58.1 years n=100 Participants • Not all patients have baseline information available
Sex: Female, Male Female	10 Participants n=54 Participants • Not all patients have baseline information available	8 Participants n=50 Participants • Not all patients have baseline information available	18 Participants n=104 Participants • Not all patients have baseline information available
Sex: Female, Male Male	44 Participants n=54 Participants • Not all patients have baseline information available	42 Participants n=50 Participants • Not all patients have baseline information available	86 Participants n=104 Participants • Not all patients have baseline information available
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Weight	85.6 kg STANDARD_DEVIATION 19.3 • n=52 Participants • Not all patients have baseline information available	79.6 kg STANDARD_DEVIATION 15.2 • n=50 Participants • Not all patients have baseline information available	82.7 kg STANDARD_DEVIATION 17.6 • n=102 Participants • Not all patients have baseline information available
Diabetic	3 Participants n=54 Participants	10 Participants n=52 Participants	13 Participants n=106 Participants
Smoker	9 Participants n=54 Participants	7 Participants n=52 Participants	16 Participants n=106 Participants
ECOG > 0	8 Participants n=54 Participants	13 Participants n=52 Participants	21 Participants n=106 Participants
Chemotherapy	31 Participants n=54 Participants	35 Participants n=52 Participants	66 Participants n=106 Participants
Radiation Therapy => 7,000 Gy	36 Participants n=54 Participants	30 Participants n=52 Participants	66 Participants n=106 Participants

PRIMARY outcome

Timeframe: Over 7 weeks of expected duration of mucositis

Population: Patients who had at least one mucositis assessment were included in this analysis

Outcome measures

Outcome measures
Measure	Honey n=40 Participants 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.	Placebo n=41 Participants 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.
Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had at Least One Mucositis Assessment	14 Participants	18 Participants

PRIMARY outcome

Timeframe: Over 7 weeks of expected duration of mucositis

Population: Patients who had a minimum of 2 mucositis assessments were included in this analysis

Outcome measures

Outcome measures
Measure	Honey n=31 Participants 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.	Placebo n=33 Participants 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.
Severity of Mucositis According to the Radiation Therapy Oncology Group (RTOG) for Patients Who Had a Minimum of 2 Mucositis Assessments	11 Participants	16 Participants

Adverse Events

Honey

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Honey n=54 participants at risk 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.	Placebo n=52 participants at risk 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.
Gastrointestinal disorders Nausea	14.8% 8/54	9.6% 5/52
Product Issues Bad Taste	0.00% 0/54	1.9% 1/52
Product Issues Burning Sensation in Mouth	3.7% 2/54	0.00% 0/52

Additional Information

Dr. Philippa Hawley

BC Cancer

Phone: (604) 877-6000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place