Childhood OncologyNCT06711315
Oral Mucositis Management in Pediatric Oncology Patients
A study testing Oral Mucosit Care Protocol in people with Childhood Oncology and Mucositis Oral, run by Zubeyde Ezgi Ercelik at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated the impact of an oral mucositis care protocol on the severity of mucositis. The main questions it aims to answer are: -What is the severity of mucositis in parents and children who receive oral mucositis education? The data were collected using a descriptive information form, the Children's… Read more about this study
- Who is it for?
- Ages 6 to 18 weeks
- Conditions the study is for
- Childhood Oncology, Mucositis Oral
- What is being tested?
- Oral Mucosit Care Protocol
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 1 Sep 2024
- 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 6 to 18 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Being between 6 and 18 years,
- Having received at least 1 course of chemotherapy,
- Having no visual, auditory, or intellectual problems
- Speaking and understanding Turkish
- Being willing to participate in the research.
Who cannot join
- -Conditions that prevent verbal communication (neurodevelopmental delay, verbal speech difficulties, hearing or hearing problems; oral mucositis).
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Zonguldak Bülent Ecevit University Training and Research Hospital
Zonguldak
About this study
Official title: Oral Mucositis Management Supported by MASCC/ISOO Protocols: A Randomized Controlled Trial in Pediatric Oncology Patients
This study evaluated the impact of an oral mucositis care protocol on the severity of mucositis.
The main questions it aims to answer are:
Read more
-What is the severity of mucositis in parents and children who receive oral mucositis education?
The data were collected using a descriptive information form, the Children's International Mucositis Evaluation Scale (ChIMES), and the WHO Oral Mucositis Grading Scale. Standard care was applied to the control group. For the intervention group, an oral care protocol was prepared, and the patients received training. The oral care intervention was applied for 14 days and monitored by the researcher. The patients were monitored for oral mucositis on Days 0, 3, 7, and 14. Those in the intervention group received a calendar for documenting their oral care practices.
Read the detailed description
Data Collection Process The researchers informed children and their parents about the purpose of the study. Written and verbal consent was obtained from both willing children and their parents.
The researcher works as a nurse in the pediatric oncology clinic. If the children met the inclusion criteria, the researchers visited the clinics, introduced themselves to the child and the family, and provided information about the research. The child and the family were informed about the research. All caregivers (both intervention and control groups) who meet the inclusion criteria and agree to participate in the study will be asked to fill out the Descriptive Characteristics Form. Research data will be obtained by conducting four assessment interviews with each child and caregiver. The first interview will be conducted before the treatment, the second interview will be conducted on the 3rd day after the treatment, and the following interviews will be conducted on the 7th and 14th days of the treatment and the oral mucosa will be evaluated by the researcher by interviewing the child and caregiver and using scales.
The child and caregiver in the intervention group will receive an oral care protocol on days 0-14 of treatment. The child and caregiver in the control group will receive standard care.
Procedures Intervention Group The children in the intervention group were subjected to a four-stage intervention carried out by the nurse researcher. The practices in each stage were as follows.
Stage 1: Oral care protocol training to prevent oral mucositis Stage 2: Introduction and application of training material (brochure) Stage 3: Introduction and implementation of oral care calendar Stage 4: Implementation of oral care protocol
Stage 1: Oral care protocol training to prevent oral mucositis Oral care protocol was prepared according to the protocols to standardize oral care practices for children and caregivers before chemotherapy treatment. Expert opinions were collected to inform the content of the training, which was administered in a single session. The training session included a PowerPoint presentation identifying the definition of oral mucositis, the cause of occurrence, signs and symptoms, and the oral care protocol. Together with each child and their caregiver who completed the training, the researcher applied the oral care protocol and answered questions. All material to be applied in the oral care protocol. was introduced to each patient in a one-on-one meeting. At the end of the training, the participants received a training brochure containing the material and application steps. Separate trainings were given to each child hospitalized in the clinic and their caregiver.
Stage 2: Introduction and application of training material (brochure) The children received a brochure with directions for using the medicine and information about how many times it should be used per day.
Stage 3: Introduction and implementation of oral care calendar Patients in the intervention group were given a calendar for documenting their oral care practices. With this calendar, the child and their caregiver and the nurse had the opportunity to track oral care practices.
Figure 4. Followed Oral Care Calendar and Training Children in the intervention group who applied and completed the care protocol for 14 days received a certificate of appreciation prepared by the researchers
Stage 4: Implementation of oral care protocol Within the scope of the study, the oral care protocol prepared on the basis of the literature was applied to the intervention group over a 14-day period. Laboratory values were monitored, and the application was evaluated during the application process.
Prior to treatment (Day 0), each child in the intervention group underwent an oral examination. Following the results of the evaluation, participants were instructed to gargle with sodium bicarbonate (5 cc) six times per day starting on Day 1 and to gargle and spit between meals. They received mouthwash with sodium chloride (5 cc) to be spit and Mycostatin (2 cc) to be swallowed after each meal. They were also asked to gargle and swallow glutamine (5 cc) three times a day before or between meals. Together with the caregiver, each participant was instructed to use dental floss after eating twice per day and then brush their teeth with a soft toothbrush and fluoride toothpaste. The American Academy of Pediatric Dentistry recommends brushing the teeth unless bleeding occurs. The American Academy of Pediatric Dentistry (2022) advises patients to maintain good oral hygiene by brushing their teeth and tongue two to three times a day, regardless of their hematological status. Flossing is reportedly effective in preventing oral mucositis but should be done under the guidance of a caregiver (Ferrández-Pujante, 2022). Finally, the participants were told to use Lanolin-containing lip moisturizer at least twice a day and to not eat or drink for half an hour after applying the moisturizer. Table 1 presents the daily oral care practice for the intervention group. Evaluations were performed on Days 0, 3, 7, and 14 of the application.
Control Group Children in the control group will receive standard care. Mouthwash with sodium bicarbonate (after each feeding), mycostatin (2x1) and tranflex (3x1). Toothbrush and dental floss are not used. At the end of the 14th day, the child and caregiver in the control group will receive Oral Care Protocol Training to Prevent Oral Mucositis.
- Conditions
- Childhood Oncology, Mucositis Oral
- Being tested
- Oral Mucosit Care Protocol
- Keywords
- Childhood, cancer, oral mucosit, oral care
- Medical subject headings
- Stomatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral Mucosit Care ProtocolBehavioural
The children in the intervention group were subjected to a four-stage intervention carried out by the nurse researcher. The practices in each stage were as follows.
Stage 1: Oral care protocol training to prevent oral mucositis Stage 2: Introduction and application of training material (brochure) Stage 3: Introduction and implementation of oral care calendar Stage 4: Implementation of oral care protocol
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Oral mucositis education was given, oral care was requested for 14 days and monitored on days 0, 3, 7 and 14. Receives: Behavioral: Oral Mucosit Care Protocol |
| Control Group | No intervention | Children in the control group will receive standard care. Mouthwash with sodium bicarbonate (after each feeding), mycostatin (2x1) and tranflex (3x1). Toothbrush and dental floss are not used. At the end of the 14th day, the child and caregiver in the control group will receive Oral Care Protocol Training to Prevent Oral Mucositis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
CHIMES scores
The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis
Measured: day0
CHIMES scores
The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis
Measured: day3
CHIMES scores
The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis
Measured: day7
CHIMES scores
The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis
Measured: day14
WHO Oral Mucositis Granding Scale
The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required
Measured: day0
WHO Oral Mucositis Granding Scale
The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required
Measured: day3
WHO Oral Mucositis Granding Scale
The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required
Measured: day7
WHO Oral Mucositis Granding Scale
The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required
Measured: day14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start1 Jun 2023
- Primary completion6 Aug 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Childhood OncologyStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zubeyde Ezgi Ercelik
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zubeyde Ezgi Ercelik, Bandırma Onyedi Eylül University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06711315
- Sponsor's protocol ID
- 2023 - 695
- Other IDs
- From Researcher
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 2 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Since the participants are children, they are not wanted to share.
Publications
Ercelik ZE, Bayram D, Erdogan B, Altay N. Effectiveness of oral mucositis management based on MASCC/ISOO guidelines in pediatric oncology patients: a randomized controlled trial. Support Care Cancer. 2026 Mar 21;34(4):349. doi: 10.1007/s00520-026-10393-8.
PubMed 41863643
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Mucositis Management Supported by MASCC/ISOO Protocols: A Randomized Controlled Trial in Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT06711315
- Acronym / sponsor ID
- 2023 - 695
- Conditions
- Childhood Oncology, Mucositis Oral
- Keywords
- Childhood, cancer, oral mucosit, oral care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Zubeyde Ezgi ErcelikUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 6 Aug 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 2 Dec 2024 (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.
This study evaluated the impact of an oral mucositis care protocol on the severity of mucositis.
The main questions it aims to answer are:
-What is the severity of mucositis in parents and children who receive oral mucositis education?
The data were collected using a descriptive information form, the Children's International Mucositis Evaluation Scale (ChIMES), and the WHO Oral Mucositis Grading Scale. Standard care was applied to the control group. For the intervention group, an oral care protocol was prepared, and the patients received training. The oral care intervention was applied for 14 days and monitored by the researcher. The patients were monitored for oral mucositis on Days 0, 3, 7, and 14. Those in the intervention group received a calendar for documenting their oral care practices.
Detailed description
Data Collection Process The researchers informed children and their parents about the purpose of the study. Written and verbal consent was obtained from both willing children and their parents.
The researcher works as a nurse in the pediatric oncology clinic. If the children met the inclusion criteria, the researchers visited the clinics, introduced themselves to the child and the family, and provided information about the research. The child and the family were informed about the research. All caregivers (both intervention and control groups) who meet the inclusion criteria and agree to participate in the study will be asked to fill out the Descriptive Characteristics Form. Research data will be obtained by conducting four assessment interviews with each child and caregiver. The first interview will be conducted before the treatment, the second interview will be conducted on the 3rd day after the treatment, and the following interviews will be conducted on the 7th and 14th days of the treatment and the oral mucosa will be evaluated by the researcher by interviewing the child and caregiver and using scales.
The child and caregiver in the intervention group will receive an oral care protocol on days 0-14 of treatment. The child and caregiver in the control group will receive standard care.
Procedures Intervention Group The children in the intervention group were subjected to a four-stage intervention carried out by the nurse researcher. The practices in each stage were as follows.
Stage 1: Oral care protocol training to prevent oral mucositis Stage 2: Introduction and application of training material (brochure) Stage 3: Introduction and implementation of oral care calendar Stage 4: Implementation of oral care protocol
Stage 1: Oral care protocol training to prevent oral mucositis Oral care protocol was prepared according to the protocols to standardize oral care practices for children and caregivers before chemotherapy treatment. Expert opinions were collected to inform the content of the training, which was administered in a single session. The training session included a PowerPoint presentation identifying the definition of oral mucositis, the cause of occurrence, signs and symptoms, and the oral care protocol. Together with each child and their caregiver who completed the training, the researcher applied the oral care protocol and answered questions. All material to be applied in the oral care protocol. was introduced to each patient in a one-on-one meeting. At the end of the training, the participants received a training brochure containing the material and application steps. Separate trainings were given to each child hospitalized in the clinic and their caregiver.
Stage 2: Introduction and application of training material (brochure) The children received a brochure with directions for using the medicine and information about how many times it should be used per day.
Stage 3: Introduction and implementation of oral care calendar Patients in the intervention group were given a calendar for documenting their oral care practices. With this calendar, the child and their caregiver and the nurse had the opportunity to track oral care practices.
Figure 4. Followed Oral Care Calendar and Training Children in the intervention group who applied and completed the care protocol for 14 days received a certificate of appreciation prepared by the researchers
Stage 4: Implementation of oral care protocol Within the scope of the study, the oral care protocol prepared on the basis of the literature was applied to the intervention group over a 14-day period. Laboratory values were monitored, and the application was evaluated during the application process.
Prior to treatment (Day 0), each child in the intervention group underwent an oral examination. Following the results of the evaluation, participants were instructed to gargle with sodium bicarbonate (5 cc) six times per day starting on Day 1 and to gargle and spit between meals. They received mouthwash with sodium chloride (5 cc) to be spit and Mycostatin (2 cc) to be swallowed after each meal. They were also asked to gargle and swallow glutamine (5 cc) three times a day before or between meals. Together with the caregiver, each participant was instructed to use dental floss after eating twice per day and then brush their teeth with a soft toothbrush and fluoride toothpaste. The American Academy of Pediatric Dentistry recommends brushing the teeth unless bleeding occurs. The American Academy of Pediatric Dentistry (2022) advises patients to maintain good oral hygiene by brushing their teeth and tongue two to three times a day, regardless of their hematological status. Flossing is reportedly effective in preventing oral mucositis but should be done under the guidance of a caregiver (Ferrández-Pujante, 2022). Finally, the participants were told to use Lanolin-containing lip moisturizer at least twice a day and to not eat or drink for half an hour after applying the moisturizer. Table 1 presents the daily oral care practice for the intervention group. Evaluations were performed on Days 0, 3, 7, and 14 of the application.
Control Group Children in the control group will receive standard care. Mouthwash with sodium bicarbonate (after each feeding), mycostatin (2x1) and tranflex (3x1). Toothbrush and dental floss are not used. At the end of the 14th day, the child and caregiver in the control group will receive Oral Care Protocol Training to Prevent Oral Mucositis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Oral Mucosit Care ProtocolOral mucositis education was given, oral care was requested for 14 days and monitored on days 0, 3, 7 and 14. |
| Control Group | No intervention | –Children in the control group will receive standard care. Mouthwash with sodium bicarbonate (after each feeding), mycostatin (2x1) and tranflex (3x1). Toothbrush and dental floss are not used. At the end of the 14th day, the child and caregiver in the control group will receive Oral Care Protocol Training to Prevent Oral Mucositis. |
Who may qualify
- Ages
- 6 to 18 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Being between 6 and 18 years,
- Having received at least 1 course of chemotherapy,
- Having no visual, auditory, or intellectual problems
- Speaking and understanding Turkish
- Being willing to participate in the research.
Key exclusion criteria (1 listed)
- -Conditions that prevent verbal communication (neurodevelopmental delay, verbal speech difficulties, hearing or hearing problems; oral mucositis).
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 Mucosit Care ProtocolThe children in the intervention group were subjected to a four-stage intervention carried out by the nurse researcher. The practices in each stage were as follows. Stage 1: Oral care protocol training to prevent oral mucositis Stage 2: Introduction and application of training material (brochure) Stage 3: Introduction and implementation of oral care calendar Stage 4: Implementation of oral care protocol | Behavioural | Intervention Group |
Primary outcome
CHIMES scores
Time frame: day0
The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis
CHIMES scores
Time frame: day3
The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis
CHIMES scores
Time frame: day7
The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis
CHIMES scores
Time frame: day14
The scale consists of categories such as the severity of pain in the mouth, the effect of pain on swallowing, eating, drinking, taking painkillers, and the presence of ulcers in the mouth.The lowest score obtained from the scale is 0, the highest score is 23. The higher the total score, the more advanced the degree of mucositis
WHO Oral Mucositis Granding Scale
Time frame: day0
The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required
WHO Oral Mucositis Granding Scale
Time frame: day3
The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required
WHO Oral Mucositis Granding Scale
Time frame: day7
The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required
WHO Oral Mucositis Granding Scale
Time frame: day14
The presence of oral mucositis is assessed based on clinical manifestations. The score ranges from 0 (the absence of manifestations and symptoms) to 4 (oral feeding is impossible). Grade-0 no change in mucosa, Grade-1 painless ulcers, erythema or mild sensitization, Grade-2 painful erythema and ulcer but can consume solid foods. Grade-3 painful erythema, edema or ulcer can consume only fluids, Grade-4 ulceration, necrosis and hemorrhage, patient cannot feed, enteral or parenteral support is required
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 2 Dec 2024.
- Derived from this study: PubMed 41863643Ercelik ZE, Bayram D, Erdogan B, Altay N. Effectiveness of oral mucositis management based on MASCC/ISOO guidelines in pediatric oncology patients: a randomized controlled trial. Support Care Cancer. 2026 Mar 21;34(4):349. doi: 10.1007/s00520-026-10393-8.
- Individual participant dataSharing planned: No. Since the participants are children, they are not wanted to share.
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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 Mucosit Care Protocol in people with Childhood Oncology and Mucositis Oral, run by Zubeyde Ezgi Ercelik 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 5 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 2 Dec 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 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?
CHIMES scores (time frame: day0). The study lists 8 primary outcomes in all. 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 NCT06711315, which also lists 1 linked publication.
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 2 Dec 2024.