Oral MucositisPhase 1NCT03399331
Honey or Olive Oil for Treating Oral Mucositis in Children and Adults With Leukemia Receiving Intensive Chemotherapy
A Phase 1 study testing Manuka honey and olive oil in people with Oral Mucositis and Leukemia, run by American University of Beirut Medical Center at 1 site in Lebanon.
Trial summary
Background: Oral mucositis (OM) is a significant complication occurring in approximately 40% of patients on chemotherapy regimens. Ulcerative lesions of OM can be very painful, with negative impact on diet, oral hygiene, and quality of life. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Oral Mucositis, Leukemia
- What is being tested?
- Manuka honey and olive oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteLebanon
- Study dates
- 10 Jul 2017to 1 Jun 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- The following are the inclusion criteria:
- Children/Adults with leukemia (ALL, AML) receiving intensive (high dose) chemotherapy treatment such as myeloablative, doxorubicin or methotrexate during induction, consolidation and re-induction therapy.
- Absence of any home remedy for mucositis
- Patients with grades 1-3 OM based on the WHO grading system.
Who cannot join
- Patients under non- intensive chemotherapeutic treatment.
- Presence of advanced or severe periodontitis (patients with periodontal pockets of 6mm or more).
- Patients with a cognitive disability which my no enable them to assess their pain
- History of allergy to honey or olive oil.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "The Efficacy of Honey or Olive Oil on the Severity and Pain of Oral Mucositis Compared to Placebo (Standard Care) in Children With Leukemia Receiving Intensive Chemotherapy
Background: Oral mucositis (OM) is a significant complication occurring in approximately 40% of patients on chemotherapy regimens. Ulcerative lesions of OM can be very painful, with negative impact on diet, oral hygiene, and quality of life. Although a wide variety of agents have been tested to prevent OM or reduce its severity, none have provided conclusive evidence.
Objectives of this study will be: to determine the efficacy of honey or olive oil on the severity and pain of OM compared to placebo (standard care) and, (2) to assess which of the two interventions is more beneficial.
Read more
Research Questions:
- Children/adults who receive honey (group 1) or olive oil (group 2) will have less severe OM compared to the control group (Severity is measured by recovery time from OM and is the primary outcome)
- Children/adults who receive honey (group 1) OR Olive oil (group 2) will have less pain than the control group. (Severity of pain is the secondary outcome Methods: A randomized controlled study (RCT) will be used to evaluate the effect of topical application of honey or olive oil, in the treatment of chemotherapy-related OM in 60 participants with OM. The primary outcome will be the severity of mucositis, assessed by four trained nurses blinded to the study group using the scale presented by the World Health Organization (WHO). The secondary outcome will be pain also assessed by the four trained nurses on the visual analogue scale ort eh Wong Faces scale.
The relevance of this study lies in the possibility of challenging nurses in regard to the problem of OM and in proving a possible herbal cure that may influence clinical practice.
Data analysis: The characteristics of the three groups will be described using mean and SD, frequencies and percentages. Baseline differences between the two groups will be tested using ANOVA for continuous data, and the Chi-square for categorical data. Kruskall-Wallis (chi square) test will be used to find the association group assignment and WHO grades of OM and ANOVA and RANOVA tests will be used to find the association between group assignment and the pain scores. Bonferroni tests will be conducted to explore which of the three groups has the better outcomes.
Read the detailed description
When parents or adults express interest in the study they will be approached by the Principal investigator (LKB) or the 2 research nurses (RS or RA) who will make contact with the children and their parents and explain the study, ,answer all their questions and concerns and inform them about the study benefits/potential risks (see recruitment script appendix B in proposal). If a parent approves to participate in the study, he/she will sign an informed consent and any child above 7 will be asked to sign an assent form. The investigator will also assure the parents that participation is totally voluntary and it is not a part of the conventional treatment and that they have the full right to refuse participating and withdraw from the study at any time, even after signing the consent.
Recruitment activities will take when the children are hospitalized at the Children's cancer center in Lebanon (CCCL), 8 North and the Bone Marrow unit (BMT). Patients, parents and children will also have access to flyers in the unit briefly explaining the study. Potential subjects will be identified through reviewing daily census on the inpatient unit of CCCL, 8 north or the BMT unit. Participates will be screened for eligibility and will be excluded if they have any condition that may affect the efficacy of treatment as listed in the exclusion criteria. Participants will be randomly assigned to 1 of 3 groups, 20 patients in each group. The randomization method will be prepared in advance by a statistician not involved in the study, using a paper list-generated random assignment sequencel. Based on group assignment, participants will receive a different compound applied topically to the oral mucosa 3 times daily until healing, or for 7 days, whichever comes first.
Group 1 will receive 10cc of honey for adults and 5 cc for children, which will be supplied directly from a New Zealand.
Group 2 will receive maximum 5 g of extra virgin olive oil for adults and 2 cc for children directly from a local distributor in south Lebanon. It will be stored in dark containers at room temperature for use in the study.
Group 3 will serve as control, which at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine).
Groups 1 and 2 patients will be instructed to slowly rinse the honey or olive oil in their mouths, swish it around for 1 minute duration, so as to make the honey or oil in contact with the oral mucosa and slowly swallow so as to make better contact with the pharyngeal mucosa. For group 3, patients will swish the respective solution for 1 minute then spit it out. The order of the different solutions will be written in each medical record by the attending physician and the nurse will observe the patient taking the solution and will document the administration on the hospital flowsheet.
The independent variable for this study is either olive oil or honey The dependent variables will be primary and secondary:
- The primary outcome will be the severity of OM measured by recovery time, defined as the number of days from the initiation of treatment until healing or day 7 assessed by four trained nurses on a daily basis and who are blinded to the study group using the scale presented by the World Health Organization (WHO). The WHO scale is based upon the ability to eat and drink combined with objective signs of mucositis, namely erythema and ulceration (7). Visualisation of the oral cavity is critical for scoring, as the presence of oral ulcers delineates a WHO mucositis grade which ranges from 0 to 4 where higher scores correspond to worse mucositis. The WHO scale is classified as follows: grade 0=normal, no mucositis; grade 1=soreness and erythema; grade 2=erythema, ulcer, can eat solids; grade 3=ulcers, require liquid diet only; grade 4=alimentation not possible. The PI will establish inte-rater reliability with the four nurses by assessing patients on the WHO scale. Each nurse will conduct the assessment and compare her/his results with the PI, this will be done until a reliability of >. 80 is achieved. Reliability will be done before the study begins and then every month until the completion of the study.
- The secondary outcome will be a pain assessed as per the institution's policy using the Visual analogue 10cm scale (VAS) or the Wong faces scale. A 0 indicates no mouth or throat pain and 10 indicates the most severe mouth or throat pain ( see appendix E in the proposal). The construct, convergent and predictive validity of the VAS and the Faces scales have been widely published (26). Pain scores of the oral mucosa will be conducted twice a daily for study purposes. The patients will be assessed by their RNs for pain which is documented in the patient charts twice per day in the morign and in the evening (even in the absence of pain).
- Conditions
- Oral Mucositis, Leukemia
- Being tested
- Manuka honey, olive oil, Control group
- Keywords
- honey, olive oil, oral mucositis, pain
- Medical subject headings
- Stomatitis, Leukemia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manuka honeyDietary supplement
5 for children or 10cc of honey for adults was ordered directly from a New Zealand company
olive oilDietary supplement
5 cc of extra virgin olive oil for adults and 2 cc for children directly from a local distributor in south Lebanon will be given.
Control groupCombination product
Control at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine).
| Study group | Role | What they receive |
|---|---|---|
| group 1 | Experimental | Efficacy of Manuka honey on severity and pain of OM compared to placebo (standard care) and to assess which of the two interventions is more beneficial. Receives: Dietary Supplement: Manuka honey |
| Group 2 | Experimental | Efficacy of olive oil on severity and pain of OM compared to placebo (standard care) and to assess which of the two interventions is more beneficial. Receives: Dietary Supplement: olive oil |
| Group 3 | Placebo comparator | The control group at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine Receives: Combination Product: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of Oral mucositis
Defined as the number of days from the initiation of treatment until healing or day 7 assessed by four trained nurses on a daily basis and who are blinded to the study group using the World Health Organization (WHO) scale. The WHO scale is based upon the ability to eat and drink combined with objective signs of mucositis, namely erythema and ulceration. Visualisation of the oral cavity is critical for scoring, as the presence of oral ulcers delineates a WHO mucositis grade which ranges from 0 to 4 where higher scores correspond to worse mucositis. The PI will establish inte-rater reliability with the four nurses by assessing patients on the WHO scale. Each nurse will conduct the assessment and compare her/his results with the PI, this will be done until a reliability of >. 80 is achieved. Reliability will be done before the study begins and then every month until the completion of the study.
Measured: 7 days or until healing or Discharge
Secondary outcomes (1)
Pain as reported by children
Pain assessed as per the institution's policy using the Visual analogue scale
Measured: 7 days or until healing or Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2018
- Study start10 Jul 2017
- Primary completion1 Dec 2021
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three groups randomized using a computer generted number sequence
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Azusa Pacific University, Daisy Foundation
- Responsible party
- Principal investigator, Lina Kordahi, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03399331
- Sponsor's protocol ID
- NUR.LB.08
- Status last verified
- Aug 2024
- First submitted
- 8 Jan 2018
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: yes
Publications
Al Jaouni SK, Al Muhayawi MS, Hussein A, Elfiki I, Al-Raddadi R, Al Muhayawi SM, Almasaudi S, Kamal MA, Harakeh S. Effects of Honey on Oral Mucositis among Pediatric Cancer Patients Undergoing Chemo/Radiotherapy Treatment at King Abdulaziz University Hospital in Jeddah, Kingdom of Saudi Arabia. Evid Based Complement Alternat Med. 2017;2017:5861024. doi: 10.1155/2017/5861024. Epub 2017 Feb 7.
PubMed 28270852Kobya Bulut H, Guducu Tufekci F. Honey prevents oral mocositis in children undergoing chemotherapy: A quasi-experimental study with a control group. Complement Ther Med. 2016 Dec;29:132-140. doi: 10.1016/j.ctim.2016.09.018. Epub 2016 Sep 19.
PubMed 27912937Xu JL, Xia R, Sun ZH, Sun L, Min X, Liu C, Zhang H, Zhu YM. Effects of honey use on the management of radio/chemotherapy-induced mucositis: a meta-analysis of randomized controlled trials. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1618-1625. doi: 10.1016/j.ijom.2016.04.023. Epub 2016 Sep 3.
PubMed 27600797Jayalekshmi JL, Lakshmi R, Mukerji A. Honey on oral mucositis: A Randomized controlled trial. Gulf J Oncolog. 2016 Jan;1(20):30-7.
PubMed 27050177Cho HK, Jeong YM, Lee HS, Lee YJ, Hwang SH. Effects of honey on oral mucositis in patients with head and neck cancer: A meta-analysis. Laryngoscope. 2015 Sep;125(9):2085-92. doi: 10.1002/lary.25233. Epub 2015 Mar 16.
PubMed 25778825Hawley P, Hovan A, McGahan CE, Saunders D. A randomized placebo-controlled trial of manuka honey for radiation-induced oral mucositis. Support Care Cancer. 2014 Mar;22(3):751-61. doi: 10.1007/s00520-013-2031-0. Epub 2013 Nov 13.
PubMed 24221577Abdulrhman M, Elbarbary NS, Ahmed Amin D, Saeid Ebrahim R. Honey and a mixture of honey, beeswax, and olive oil-propolis extract in treatment of chemotherapy-induced oral mucositis: a randomized controlled pilot study. Pediatr Hematol Oncol. 2012 Apr;29(3):285-92. doi: 10.3109/08880018.2012.669026.
PubMed 22475306Song JJ, Twumasi-Ankrah P, Salcido R. Systematic review and meta-analysis on the use of honey to protect from the effects of radiation-induced oral mucositis. Adv Skin Wound Care. 2012 Jan;25(1):23-8. doi: 10.1097/01.ASW.0000410687.14363.a3.
PubMed 22218067
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "The Efficacy of Honey or Olive Oil on the Severity and Pain of Oral Mucositis Compared to Placebo (Standard Care) in Children With Leukemia Receiving Intensive Chemotherapy
- ClinicalTrials.gov ID
- NCT03399331
- Acronym / sponsor ID
- NUR.LB.08
- Conditions
- Oral Mucositis, Leukemia
- Keywords
- honey, olive oil, oral mucositis, pain
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Azusa Pacific University, Daisy Foundation
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 16 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background: Oral mucositis (OM) is a significant complication occurring in approximately 40% of patients on chemotherapy regimens. Ulcerative lesions of OM can be very painful, with negative impact on diet, oral hygiene, and quality of life. Although a wide variety of agents have been tested to prevent OM or reduce its severity, none have provided conclusive evidence.
Objectives of this study will be: to determine the efficacy of honey or olive oil on the severity and pain of OM compared to placebo (standard care) and, (2) to assess which of the two interventions is more beneficial.
Research Questions:
- Children/adults who receive honey (group 1) or olive oil (group 2) will have less severe OM compared to the control group (Severity is measured by recovery time from OM and is the primary outcome)
- Children/adults who receive honey (group 1) OR Olive oil (group 2) will have less pain than the control group. (Severity of pain is the secondary outcome Methods: A randomized controlled study (RCT) will be used to evaluate the effect of topical application of honey or olive oil, in the treatment of chemotherapy-related OM in 60 participants with OM. The primary outcome will be the severity of mucositis, assessed by four trained nurses blinded to the study group using the scale presented by the World Health Organization (WHO). The secondary outcome will be pain also assessed by the four trained nurses on the visual analogue scale ort eh Wong Faces scale.
The relevance of this study lies in the possibility of challenging nurses in regard to the problem of OM and in proving a possible herbal cure that may influence clinical practice.
Data analysis: The characteristics of the three groups will be described using mean and SD, frequencies and percentages. Baseline differences between the two groups will be tested using ANOVA for continuous data, and the Chi-square for categorical data. Kruskall-Wallis (chi square) test will be used to find the association group assignment and WHO grades of OM and ANOVA and RANOVA tests will be used to find the association between group assignment and the pain scores. Bonferroni tests will be conducted to explore which of the three groups has the better outcomes.
Detailed description
When parents or adults express interest in the study they will be approached by the Principal investigator (LKB) or the 2 research nurses (RS or RA) who will make contact with the children and their parents and explain the study, ,answer all their questions and concerns and inform them about the study benefits/potential risks (see recruitment script appendix B in proposal). If a parent approves to participate in the study, he/she will sign an informed consent and any child above 7 will be asked to sign an assent form. The investigator will also assure the parents that participation is totally voluntary and it is not a part of the conventional treatment and that they have the full right to refuse participating and withdraw from the study at any time, even after signing the consent.
Recruitment activities will take when the children are hospitalized at the Children's cancer center in Lebanon (CCCL), 8 North and the Bone Marrow unit (BMT). Patients, parents and children will also have access to flyers in the unit briefly explaining the study. Potential subjects will be identified through reviewing daily census on the inpatient unit of CCCL, 8 north or the BMT unit. Participates will be screened for eligibility and will be excluded if they have any condition that may affect the efficacy of treatment as listed in the exclusion criteria. Participants will be randomly assigned to 1 of 3 groups, 20 patients in each group. The randomization method will be prepared in advance by a statistician not involved in the study, using a paper list-generated random assignment sequencel. Based on group assignment, participants will receive a different compound applied topically to the oral mucosa 3 times daily until healing, or for 7 days, whichever comes first.
Group 1 will receive 10cc of honey for adults and 5 cc for children, which will be supplied directly from a New Zealand.
Group 2 will receive maximum 5 g of extra virgin olive oil for adults and 2 cc for children directly from a local distributor in south Lebanon. It will be stored in dark containers at room temperature for use in the study.
Group 3 will serve as control, which at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine).
Groups 1 and 2 patients will be instructed to slowly rinse the honey or olive oil in their mouths, swish it around for 1 minute duration, so as to make the honey or oil in contact with the oral mucosa and slowly swallow so as to make better contact with the pharyngeal mucosa. For group 3, patients will swish the respective solution for 1 minute then spit it out. The order of the different solutions will be written in each medical record by the attending physician and the nurse will observe the patient taking the solution and will document the administration on the hospital flowsheet.
The independent variable for this study is either olive oil or honey The dependent variables will be primary and secondary:
- The primary outcome will be the severity of OM measured by recovery time, defined as the number of days from the initiation of treatment until healing or day 7 assessed by four trained nurses on a daily basis and who are blinded to the study group using the scale presented by the World Health Organization (WHO). The WHO scale is based upon the ability to eat and drink combined with objective signs of mucositis, namely erythema and ulceration (7). Visualisation of the oral cavity is critical for scoring, as the presence of oral ulcers delineates a WHO mucositis grade which ranges from 0 to 4 where higher scores correspond to worse mucositis. The WHO scale is classified as follows: grade 0=normal, no mucositis; grade 1=soreness and erythema; grade 2=erythema, ulcer, can eat solids; grade 3=ulcers, require liquid diet only; grade 4=alimentation not possible. The PI will establish inte-rater reliability with the four nurses by assessing patients on the WHO scale. Each nurse will conduct the assessment and compare her/his results with the PI, this will be done until a reliability of >. 80 is achieved. Reliability will be done before the study begins and then every month until the completion of the study.
- The secondary outcome will be a pain assessed as per the institution's policy using the Visual analogue 10cm scale (VAS) or the Wong faces scale. A 0 indicates no mouth or throat pain and 10 indicates the most severe mouth or throat pain ( see appendix E in the proposal). The construct, convergent and predictive validity of the VAS and the Faces scales have been widely published (26). Pain scores of the oral mucosa will be conducted twice a daily for study purposes. The patients will be assessed by their RNs for pain which is documented in the patient charts twice per day in the morign and in the evening (even in the absence of pain).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- three groups randomized using a computer generted number sequence
| Arm | Type | Receives |
|---|---|---|
| group 1 | Experimental | Dietary Supplement: Manuka honeyEfficacy of Manuka honey on severity and pain of OM compared to placebo (standard care) and to assess which of the two interventions is more beneficial. |
| Group 2 | Experimental | Dietary Supplement: olive oilEfficacy of olive oil on severity and pain of OM compared to placebo (standard care) and to assess which of the two interventions is more beneficial. |
| Group 3 | Placebo comparator | Combination Product: Control groupThe control group at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Children/Adults with leukemia (ALL, AML) receiving intensive (high dose) chemotherapy treatment such as myeloablative, doxorubicin or methotrexate during induction, consolidation and re-induction therapy.
- Absence of any home remedy for mucositis
- Patients with grades 1-3 OM based on the WHO grading system.
Key exclusion criteria (4 listed)
- Patients under non- intensive chemotherapeutic treatment.
- Presence of advanced or severe periodontitis (patients with periodontal pockets of 6mm or more).
- Patients with a cognitive disability which my no enable them to assess their pain
- History of allergy to honey or olive oil.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manuka honey5 for children or 10cc of honey for adults was ordered directly from a New Zealand company | Dietary supplement | group 1 |
| olive oil5 cc of extra virgin olive oil for adults and 2 cc for children directly from a local distributor in south Lebanon will be given. | Dietary supplement | Group 2 |
| Control groupControl at our institution is 5cc sodium bicarbonate, 5cc rinsidin and 5cc of mycostatin 4 times daily for children. For adults it is Caphosol in the BMT unit and in the Basile inpatient unit it is the magic solution (without xylocaine). | Combination product | Group 3 |
Primary outcome
The severity of Oral mucositis
Time frame: 7 days or until healing or Discharge
Defined as the number of days from the initiation of treatment until healing or day 7 assessed by four trained nurses on a daily basis and who are blinded to the study group using the World Health Organization (WHO) scale. The WHO scale is based upon the ability to eat and drink combined with objective signs of mucositis, namely erythema and ulceration. Visualisation of the oral cavity is critical for scoring, as the presence of oral ulcers delineates a WHO mucositis grade which ranges from 0 to 4 where higher scores correspond to worse mucositis. The PI will establish inte-rater reliability with the four nurses by assessing patients on the WHO scale. Each nurse will conduct the assessment and compare her/his results with the PI, this will be done until a reliability of >. 80 is achieved. Reliability will be done before the study begins and then every month until the completion of the study.
1 secondary outcome
Pain as reported by children
Time frame: 7 days or until healing or Discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Background: PubMed 28270852Al Jaouni SK, Al Muhayawi MS, Hussein A, Elfiki I, Al-Raddadi R, Al Muhayawi SM, Almasaudi S, Kamal MA, Harakeh S. Effects of Honey on Oral Mucositis among Pediatric Cancer Patients Undergoing Chemo/Radiotherapy Treatment at King Abdulaziz University Hospital in Jeddah, Kingdom of Saudi Arabia. Evid Based Complement Alternat Med. 2017;2017:5861024. doi: 10.1155/2017/5861024. Epub 2017 Feb 7.
- Background: PubMed 27912937Kobya Bulut H, Guducu Tufekci F. Honey prevents oral mocositis in children undergoing chemotherapy: A quasi-experimental study with a control group. Complement Ther Med. 2016 Dec;29:132-140. doi: 10.1016/j.ctim.2016.09.018. Epub 2016 Sep 19.
- Background: PubMed 27600797Xu JL, Xia R, Sun ZH, Sun L, Min X, Liu C, Zhang H, Zhu YM. Effects of honey use on the management of radio/chemotherapy-induced mucositis: a meta-analysis of randomized controlled trials. Int J Oral Maxillofac Surg. 2016 Dec;45(12):1618-1625. doi: 10.1016/j.ijom.2016.04.023. Epub 2016 Sep 3.
- Background: PubMed 27050177Jayalekshmi JL, Lakshmi R, Mukerji A. Honey on oral mucositis: A Randomized controlled trial. Gulf J Oncolog. 2016 Jan;1(20):30-7.
- Background: PubMed 25778825Cho HK, Jeong YM, Lee HS, Lee YJ, Hwang SH. Effects of honey on oral mucositis in patients with head and neck cancer: A meta-analysis. Laryngoscope. 2015 Sep;125(9):2085-92. doi: 10.1002/lary.25233. Epub 2015 Mar 16.
- Background: PubMed 24221577Hawley P, Hovan A, McGahan CE, Saunders D. A randomized placebo-controlled trial of manuka honey for radiation-induced oral mucositis. Support Care Cancer. 2014 Mar;22(3):751-61. doi: 10.1007/s00520-013-2031-0. Epub 2013 Nov 13.
- Background: PubMed 22475306Abdulrhman M, Elbarbary NS, Ahmed Amin D, Saeid Ebrahim R. Honey and a mixture of honey, beeswax, and olive oil-propolis extract in treatment of chemotherapy-induced oral mucositis: a randomized controlled pilot study. Pediatr Hematol Oncol. 2012 Apr;29(3):285-92. doi: 10.3109/08880018.2012.669026.
- Background: PubMed 22218067Song JJ, Twumasi-Ankrah P, Salcido R. Systematic review and meta-analysis on the use of honey to protect from the effects of radiation-induced oral mucositis. Adv Skin Wound Care. 2012 Jan;25(1):23-8. doi: 10.1097/01.ASW.0000410687.14363.a3.
- Individual participant dataSharing planned: Undecided. yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Manuka honey and olive oil in people with Oral Mucositis and Leukemia, run by American University of Beirut Medical Center at 1 site in Lebanon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of Oral mucositis (time frame: 7 days or until healing or Discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03399331, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.