Oral MucositisNCT04800549
Effect of Black Mulberry Lollipop on Prevention of Oral Mucositis in Children
A study testing Oral Mucositis in people with Oral Mucositis, run by Sapanca Ilce Devlet Hastanesi at 1 site in Turkey (Türkiye).
Trial summary
THE EFFECT OF BLACK MULBERRY LOLLIPOP AND SODIUM BICARBONATE USED IN ORAL CARE ON PREVENTION OF ORAL MUCOSITIS AMONG CHILDREN RECEIVING CHEMOTHERAPY DUE TO CANCER Read more about this study
- Who is it for?
- Ages 3 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Oral Mucositis
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 69 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2016to Feb 2017
- Phase
- Interventional
- 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 3 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Being in the age group of 3-18 years
- Being hospitalised for chemotherapy treatment
- Not having oral mucositis
- No using another method to protect oral mucosa during the study period
- Not having the history of black mulberry (similar fruit berries, blackberries, etc.) allergy
- Not having intolerance to cold
Who cannot join
- -Not having food in mouth
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Sağlık Bakanlığı Sapanca Ilçe Hastanesi
Sakarya, Türkiye, 54600
About this study
Official title: The Effect of Black Mulberry Lollipop and Sodium Bicarbonate Used in Oral Care on Prevention of Oral Mucositis Among Children Receiving Chemotherapy Due to Cancer
THE EFFECT OF BLACK MULBERRY LOLLIPOP AND SODIUM BICARBONATE USED IN ORAL CARE ON PREVENTION OF ORAL MUCOSITIS AMONG CHILDREN RECEIVING CHEMOTHERAPY DUE TO CANCER
Read the detailed description
The study was conducted experimentally to determine the effect of black mulberry lollipop and sodium bicarbonate used in oral care on prevention of oral mucositis in children followed up due to the diagnosis of cancer. Sodium bicarbonate and black mulberry treatment were compared to prevent oral mucositis in 69 children receiving chemotherapy due to cancer. While 35 children were assigned to the experimental group (sodium bicarbonate + black mulberry lollipop application), 34 were assigned to the control group (sodium bicarbonate application).
- Conditions
- Oral Mucositis
- Being tested
- Oral Mucositis
- Keywords
- Keywords: chemotherapy, oral mucositis, black mulberry, bicarbonate, paediatric oncology
- Medical subject headings
- Stomatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral MucositisOther
The data of the study were obtained by conducting six interviews with each child and the family. The first interview was conducted before starting to treatment on the first day of the treatment, the second interview was conducted on the 2nd day after the treatment and the following interviews were conducted on the 4th, 8th, 16th, and 21st days and in-mouth mucosa of the patient was evaluated by taking in-mouth pictures following interviewing with the child and the family. Oral care application was conducted four times a day with sodium bicarbonate solution and a lollipop made with black mulberry syrup (after meals and before going to the bed at night). Oral care was first conducted by the researcher, the oral care was then taught to the patient and patient's relatives and the application was evaluated. Figure 1 shows the study design.
| Study group | Role | What they receive |
|---|---|---|
| METHOD | Experimental | The power of the test in the study was calculated by using G*Power 3.1 program. While Type I error is 0.05 and the power of the test is 0.80 (α= 0.05, 1-β= 0.80), minimal sample size was calculated as 62 children (31 children in each group). By considering the losses that may occur from the sample during the study due to any reason, it was planned to include 40 children in both experimental and control groups. Follow-up lost occurred in 5 patients from experimental group and 6 patients in the control group during the study. The study was completed with 69 paediatric patients including 34 in the experimental group and 35 in the control group. Receives: Other: Oral Mucositis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Follow-up Form
It has 16 questions prepared by the researcher utilising literature and including sociodemographic characteristic and oral care habits of the child and family.
Measured: 3 minute
Children's International Mucositis Evaluation Scale
Tomlison et al. (2010) developed Children's International Mucositis Evaluation Scale (ChIMES) in order to evaluate the difficulty experienced by children with cancer due to mouth/throat pain developing depending on mucositis. Yavuz et al., (2011) conducted the validity and reliability study of the Turkish version of the scale. The scale consists of six (6) questions and it is an easy-to-apply form that can be answered with the child's facial expressions.
Measured: 2 minute
Nurse Observation Chart of Child Mucositis Evaluation
It was prepared in parallel with Oral Mucositis Evaluation Index of the World Health Organization and formed to monitor formation or level of oral mucositis in children on the first, second, fourth, eights, sixteenth and twenty first days.
Measured: 10 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2021
- Study startFeb 2016
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The power of the test in the study was calculated by using G\*Power 3.1 program. While Type I error is 0.05 and the power of the test is 0.80 (α= 0.05, 1-β= 0.80), minimal sample size was calculated as 62 children (31 children in each group). By considering the losses that may occur from the sample during the study due to any reason, it was planned to include 40 children in both experimental and control groups. Follow-up lost occurred in 5 patients from experimental group and 6 patients in the control group during the study. The study was completed with 69 paediatric patients including 34 in the experimental group and 35 in the control group.
- Masking
- None (open label)
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sapanca Ilce Devlet Hastanesi
- Sponsor type
- Other government
- Collaborators
- Okan University
- Responsible party
- Principal investigator, ebru kaya, Sapanca Ilce Devlet Hastanesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04800549
- Sponsor's protocol ID
- SapancaH
- Status last verified
- Mar 2021
- First submitted
- 13 Dec 2019
- Last updated
- 16 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Black Mulberry Lollipop and Sodium Bicarbonate Used in Oral Care on Prevention of Oral Mucositis Among Children Receiving Chemotherapy Due to Cancer
- ClinicalTrials.gov ID
- NCT04800549
- Acronym / sponsor ID
- SapancaH
- Conditions
- Oral Mucositis
- Keywords
- Keywords: chemotherapy, oral mucositis, black mulberry, bicarbonate, paediatric oncology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- Sapanca Ilce Devlet HastanesiOther government
- Collaborators
- Okan University
- Study start
- Feb 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 16 Mar 2021 (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.
THE EFFECT OF BLACK MULBERRY LOLLIPOP AND SODIUM BICARBONATE USED IN ORAL CARE ON PREVENTION OF ORAL MUCOSITIS AMONG CHILDREN RECEIVING CHEMOTHERAPY DUE TO CANCER
Detailed description
The study was conducted experimentally to determine the effect of black mulberry lollipop and sodium bicarbonate used in oral care on prevention of oral mucositis in children followed up due to the diagnosis of cancer. Sodium bicarbonate and black mulberry treatment were compared to prevent oral mucositis in 69 children receiving chemotherapy due to cancer. While 35 children were assigned to the experimental group (sodium bicarbonate + black mulberry lollipop application), 34 were assigned to the control group (sodium bicarbonate application).
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The power of the test in the study was calculated by using G*Power 3.1 program. While Type I error is 0.05 and the power of the test is 0.80 (α= 0.05, 1-β= 0.80), minimal sample size was calculated as 62 children (31 children in each group). By considering the losses that may occur from the sample during the study due to any reason, it was planned to include 40 children in both experimental and control groups. Follow-up lost occurred in 5 patients from experimental group and 6 patients in the control group during the study. The study was completed with 69 paediatric patients including 34 in the experimental group and 35 in the control group.
| Arm | Type | Receives |
|---|---|---|
| METHOD | Experimental | Other: Oral MucositisThe power of the test in the study was calculated by using G*Power 3.1 program. While Type I error is 0.05 and the power of the test is 0.80 (α= 0.05, 1-β= 0.80), minimal sample size was calculated as 62 children (31 children in each group). By considering the losses that may occur from the sample during the study due to any reason, it was planned to include 40 children in both experimental and control groups. Follow-up lost occurred in 5 patients from experimental group and 6 patients in the control group during the study. The study was completed with 69 paediatric patients including 34 in the experimental group and 35 in the control group. |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Being in the age group of 3-18 years
- Being hospitalised for chemotherapy treatment
- Not having oral mucositis
- No using another method to protect oral mucosa during the study period
- Not having the history of black mulberry (similar fruit berries, blackberries, etc.) allergy
Key exclusion criteria (1 listed)
- -Not having food in mouth
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 |
|---|---|---|
| Oral MucositisThe data of the study were obtained by conducting six interviews with each child and the family. The first interview was conducted before starting to treatment on the first day of the treatment, the second interview was conducted on the 2nd day after the treatment and the following interviews were conducted on the 4th, 8th, 16th, and 21st days and in-mouth mucosa of the patient was evaluated by taking in-mouth pictures following interviewing with the child and the family. Oral care application was conducted four times a day with sodium bicarbonate solution and a lollipop made with black mulberry syrup (after meals and before going to the bed at night). Oral care was first conducted by the researcher, the oral care was then taught to the patient and patient's relatives and the application was evaluated. Figure 1 shows the study design. | Other | METHOD |
Primary outcome
Patient Follow-up Form
Time frame: 3 minute
It has 16 questions prepared by the researcher utilising literature and including sociodemographic characteristic and oral care habits of the child and family.
Children's International Mucositis Evaluation Scale
Time frame: 2 minute
Tomlison et al. (2010) developed Children's International Mucositis Evaluation Scale (ChIMES) in order to evaluate the difficulty experienced by children with cancer due to mouth/throat pain developing depending on mucositis. Yavuz et al., (2011) conducted the validity and reliability study of the Turkish version of the scale. The scale consists of six (6) questions and it is an easy-to-apply form that can be answered with the child's facial expressions.
Nurse Observation Chart of Child Mucositis Evaluation
Time frame: 10 minute
It was prepared in parallel with Oral Mucositis Evaluation Index of the World Health Organization and formed to monitor formation or level of oral mucositis in children on the first, second, fourth, eights, sixteenth and twenty first days.
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 16 Mar 2021.
- Individual participant dataSharing planned: Undecided
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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 study testing Oral Mucositis in people with Oral Mucositis, run by Sapanca Ilce Devlet Hastanesi at 1 site in Turkey (Türkiye).
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 6 inclusion and 1 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 16 Mar 2021. 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 Turkey (Türkiye). 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Patient Follow-up Form (time frame: 3 minute). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Mar 2021.