MucositisNCT04586491
The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
A study testing Oral care protocol in people with Mucositis and Pediatric Cancer, run by Dokuz Eylul University at 1 site in Turkey (Türkiye).
Trial summary
This study conducted to determine the effects of two oral care protocols containing sodium bicarbonate or saline solution in the prevention of oral mucositis (OM), mucositis degree, and recovery time in children with cancer. Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Mucositis, Pediatric Cancer, Oral Cavity
- What is being tested?
- Oral care protocol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 Oct 2019to 10 Feb 2020
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- have cancer, aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics and whose families agreed to their participation in the study.
Who cannot join
- who have oral ulceration or mucositis, in terminal period, taking any antiviral or antifungal therapy for OM before enrollment in the study.
Trial locations and contacts
1 site in 1 country.
About this study
This study conducted to determine the effects of two oral care protocols containing sodium bicarbonate or saline solution in the prevention of oral mucositis (OM), mucositis degree, and recovery time in children with cancer.
Read the detailed description
The study conducted as a randomized controlled trial with a parallel design with two groups; Study group/ Oral care protocol with saline solution Control group/ Oral care protocol with sodium bicarbonate solution
Study Hypothesis; There is a difference in oral mucositis (OM) between groups. There is a difference in the degree of OM between groups. There is a difference in the OM recovery time between groups. There is a difference in demographic variables in patients with and without mucositis.
The study sample was comprised of 43 children with cancer aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics, and whose families agreed to their participation in the study. Patients excluded who have oral ulceration or mucositis, taking any antiviral or antifungal therapy for OM before enrollment in the study. This trial was a triple blinded which the patients/parents, nurses, and the investigators have no idea about the groups.
In the study, patients were allocated by the blocked randomization. After naturally separating the gender variable into 2 layers, the age was divided into 5 layers as "<1 year, 1-3 years,>3-6 years, 6-12 years,>12 years", and the diagnosis variable was divided into 3 layers as "ALL, AML and oncological tumors."
Socio-Demographic Data Collection Form, International Child Mucositis Rating Scale (CHIMES), and Mucositis Follow-up Form used.
The child who do not have mucositis and who will be hospitalized for more than 3 days for chemotherapy will be distributed to the groups by stratified randomization method, the information of the patients will be obtained with the sociodemographic data collection form, oral care training will be given to the patient and the family, oral care protocol will be applied and it will be evaluated daily with the CHIMES and Mucositis Follow-up Form, and the severity of mucositis according to the World Health Organization Mucositis Assessment Index, the mean score of the CHIMES, recovery time will be monitored through the Mucositis Follow-up Form.
- Conditions
- Mucositis, Pediatric Cancer, Oral Cavity
- Being tested
- Oral care protocol
- Medical subject headings
- Mucositis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral care protocolCombination product
Also called Daily evaluation of the inside of the mouth with the ChIMES, Gargle with solution, wiping the inside of the mouth with solution and sterile sponge, Brushing teeth with a soft toothbrush if platelet value was > 50000mm3.
Oral care protocol
| Study group | Role | What they receive |
|---|---|---|
| Study group/ Oral care protocol with saline solution | Experimental | All patients took oral care protocol in the unit with saline solution Receives: Combination Product: Oral care protocol |
| Control group/ Oral care protocol with sodium bicarbonate solution | Experimental | All patients took oral care protocol in the unit with sodium bicarbonate solution Receives: Combination Product: Oral care protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
development of oral mucositis
WHO Oral Mucositis Grading Scale: The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis.
WHO Oral Mucositis Grading Scale
Measured: until discharge from the hospital an average 1 week
Secondary outcomes (2)
severity of oral mucositis
WHO Oral Mucositis Grading Scale: The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis.
the Children's International Mucositis Evaluation Scale (ChIMES):It consists of seven elements: (1) Amount of mouth or throat pain(ChIMES1), (2) Effect of mouth or throat pain on swallowing(ChIMES2), (3) Effect of mouth or throat pain oneating (ChIMES3), (4) Effect of mouth or throat pain ondrinking (ChIMES4), (5) Receipt of pain medication (ChIMES5),(6) Receipt of pain medication for mouth or throat pain(ChIMES6), and (7) Presence of ulcers (ChIMES7).
Measured: until discharge from the hospital an average 1 week
recovery time of oral mucositis
Mucositis Follow-up Form used for the recovery time
Measured: until discharge from the hospital an average 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start7 Oct 2019
- Primary completion10 Feb 2020
- Study completion10 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomised, parallel trial design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dokuz Eylul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülçin Özalp Gerçeker, Dokuz Eylul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586491
- Sponsor's protocol ID
- Gülçin Özalp Gerçeker
- Status last verified
- Oct 2020
- First submitted
- 12 Oct 2020
- Last updated
- 19 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
- ClinicalTrials.gov ID
- NCT04586491
- Acronym / sponsor ID
- Gülçin Özalp Gerçeker
- Conditions
- Mucositis, Pediatric Cancer, Oral Cavity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Dokuz Eylul UniversityUniversity, hospital or other
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- 10 Feb 2020 (actual)
- Study completion
- 10 Feb 2020 (actual)
- First posted
- 14 Oct 2020 (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 conducted to determine the effects of two oral care protocols containing sodium bicarbonate or saline solution in the prevention of oral mucositis (OM), mucositis degree, and recovery time in children with cancer.
Detailed description
The study conducted as a randomized controlled trial with a parallel design with two groups; Study group/ Oral care protocol with saline solution Control group/ Oral care protocol with sodium bicarbonate solution
Study Hypothesis; There is a difference in oral mucositis (OM) between groups. There is a difference in the degree of OM between groups. There is a difference in the OM recovery time between groups. There is a difference in demographic variables in patients with and without mucositis.
The study sample was comprised of 43 children with cancer aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics, and whose families agreed to their participation in the study. Patients excluded who have oral ulceration or mucositis, taking any antiviral or antifungal therapy for OM before enrollment in the study. This trial was a triple blinded which the patients/parents, nurses, and the investigators have no idea about the groups.
In the study, patients were allocated by the blocked randomization. After naturally separating the gender variable into 2 layers, the age was divided into 5 layers as "<1 year, 1-3 years,>3-6 years, 6-12 years,>12 years", and the diagnosis variable was divided into 3 layers as "ALL, AML and oncological tumors."
Socio-Demographic Data Collection Form, International Child Mucositis Rating Scale (CHIMES), and Mucositis Follow-up Form used.
The child who do not have mucositis and who will be hospitalized for more than 3 days for chemotherapy will be distributed to the groups by stratified randomization method, the information of the patients will be obtained with the sociodemographic data collection form, oral care training will be given to the patient and the family, oral care protocol will be applied and it will be evaluated daily with the CHIMES and Mucositis Follow-up Form, and the severity of mucositis according to the World Health Organization Mucositis Assessment Index, the mean score of the CHIMES, recovery time will be monitored through the Mucositis Follow-up Form.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Prospective, randomised, parallel trial design
| Arm | Type | Receives |
|---|---|---|
| Study group/ Oral care protocol with saline solution | Experimental | Combination Product: Oral care protocolAll patients took oral care protocol in the unit with saline solution |
| Control group/ Oral care protocol with sodium bicarbonate solution | Experimental | Combination Product: Oral care protocolAll patients took oral care protocol in the unit with sodium bicarbonate solution |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- have cancer, aged 1-17 years, received chemotherapy for ≥3 days at inpatient clinics and whose families agreed to their participation in the study.
Key exclusion criteria (1 listed)
- who have oral ulceration or mucositis, in terminal period, taking any antiviral or antifungal therapy for OM before enrollment in the study.
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 care protocolAlso: Daily evaluation of the inside of the mouth with the ChIMES, Gargle with solution, wiping the inside of the mouth with solution and sterile sponge, Brushing teeth with a soft toothbrush if platelet value was > 50000mm3.Oral care protocol | Combination product | Control group/ Oral care protocol with sodium bicarbonate solution, Study group/ Oral care protocol with saline solution |
Primary outcome
development of oral mucositis
Time frame: until discharge from the hospital an average 1 week
WHO Oral Mucositis Grading Scale: The WHO scale is dependent on both objective and subjective variables, and measures anatomical, symptomatic as well as functional components of oral mucositis. WHO Oral Mucositis Grading Scale
2 secondary outcomes
severity of oral mucositis
Time frame: until discharge from the hospital an average 1 week
recovery time of oral mucositis
Time frame: until discharge from the hospital an average 1 week
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 19 Oct 2020.
- Individual participant dataSharing planned: No
Related trials for Mucositis
RecruitingPhase 2
Traditional Chinese Medicine Preparation Alleviates Radiotherapy-induced Oral Mucositis in Head and Neck Cancer Patients.
Radiotherapy-induced Oral Mucositis
RecruitingObservational study
Evaluation of 25(OH)D3 and LL-37 Levels in Periimplant Sulcus Fluid
Peri Implantitis, Peri Implant Mucositis
RecruitingPhase 2
Taurine for the Prevention and Treatment of Radiation-induced Oral Mucositis in Patients With Nasopharyngeal Carcinoma
Oral Mucositis (Ulcerative) Due to Radiation, Nasopharyngeal Carcinoma (NPC)
Recruiting
Home-Use Dual-Light Antibacterial Photodynamic Therapy for Peri-Implant Mucositis in Full-Arch Implant Prostheses
Peri Implant Mucositis, Dental Implant Rehabilitation
Not yet recruitingPhase 1
A Study of Phenytoin Mucoadhesive Film for Oral Ulcers in Healthy Volunteers
Oral Ulcer, Oral Mucositis
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 care protocol in people with Mucositis and Pediatric Cancer, run by Dokuz Eylul University 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 1 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 19 Oct 2020. 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?
development of oral mucositis (time frame: until discharge from the hospital an average 1 week). 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 19 Oct 2020.