Oral MucositisNCT05849571
Investigation of the Effect of Oral Care With Coconut Oil on the Degree of Oral Mucositis in Pediatric Oncology Patients
A study testing coconut oil in people with Oral Mucositis, run by Büşra Ekinci at 1 site in Turkey (Türkiye).
Trial summary
Oral mucositis is characterized by ulcerative and inflammatory changes in the oral mucosa and is frequently seen in pediatric oncology patients receiving chemotherapy. Oral mucositis negatively affects the child's daily life functions, nutrition and quality of life. Read more about this study
- Who is it for?
- Ages 7 to 18 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- coconut oil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2023to 1 Oct 2023
- 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 7 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Being between 7-18 years old,
- Having been diagnosed with cancer,
- Receiving chemotherapy at least every 21 or 28 days,
- Willingness and volunteering to participate in the study,
- Being able to speak Turkish and express himself
Who cannot join
- Not being healthy inside the mouth before chemotherapy,
- Being in terminal period,
- Being receiving radiotherapy
- Not willing or voluntarily to participate in the study,
- Not knowing Turkish.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Başakşehir Çam and Sakura City Hospital
Istanbul, 34000
About this study
Oral mucositis is characterized by ulcerative and inflammatory changes in the oral mucosa and is frequently seen in pediatric oncology patients receiving chemotherapy. Oral mucositis negatively affects the child's daily life functions, nutrition and quality of life. Pain is the most commonly reported side effect in mucositis. Pain impairs patients' ability to chew, swallow and speak, leading to inadequate fluid/nutrient intake, malnutrition and communication problems. Weight loss, dehydration, mucosal ulceration, fluid-electrolyte imbalance may develop in patients who cannot be fed adequately, and total parenteral nutrition (TPN) can be started. Other important complications of oral mucositis are oral bleeding and infection. The ulcerated oral mucosa creates an entrance gate for microorganisms, increasing the risk of bacterial/fungal/viral infections. Infections may be limited only to the oral mucosa, as well as systemic infection and septicemia. As a result, the length of hospital stay of the patients increases, the treatment costs increase and their quality of life deteriorates. Therefore, early diagnosis of oral mucositis, planning and implementation of oral care are important. Responsibility of nurses in the management of oral mucositis; monitoring the oral cavity for symptoms, diagnosing mucositis, providing appropriate oral care, and educating patients.
In this context, it is extremely important to prevent oral mucositis, to evaluate the oral mucosa using a scale, and to reduce the degree of oral mucositis, that is, to perform appropriate oral care for its recovery, in terms of preventing other health problems and ensuring the well-being of the child. The aim of this thesis is to determine the effect of oral care with coconut oil on the degree of oral mucositis in pediatric oncology patients.
Read the detailed description
Cancers have an important place among the childhood health problems. Although deaths in childhood cancers have decreased in recent years, it has been reported that the incidence of cancer has increased. Although the incidence of childhood cancers is lower than that of adult cancers, 0.5% of all cancer cases are children under the age of 15. Treatments such as chemotherapy, radiotherapy, surgical treatment, and bone marrow transplantation are applied alone or in combination in cancer treatment. Chemotherapy, which is one of the most used treatment methods in childhood cancers, destroys cancer cells, can prevent the spread of cancer cells in the body and the recurrence of the disease by 60-70%. Chemotherapy can cause complications by affecting normal cells and tissues as well as cancer cells. Among these complications, anemia, alopecia, dermatitis, thrombocytopenia, mucositis, nausea-vomiting and pain are the most common complications. Oral mucositis is one of the most common complications after chemotherapy and is seen in approximately 52% to 80% of children receiving treatment. Oral mucositis can directly affect the individual's quality of life by causing major problems such as shedding of the oral mucosal skin, ulceration, bleeding, pain, bacterial, fungal and viral infections in sick individuals. These problems make it difficult for the child to eat, drink, swallow and speak, and may lead to the development of biopsychosocial problems such as changes in comfort, decrease in body image and self-esteem, and increase in hospitalization time and hospital cost. It is important to prevent and manage mucositis in order to increase the quality of life of these children and reduce their stress levels. Proper oral hygiene and care practices are effective in the prevention and management of mucositis. Oral care provided by nurses is very important. Nurses, who play a primary role in patient care, are responsible for oral care and the prevention of mucositis. In order to prevent the development of mucositis, nurses need to have sufficient knowledge and skills, comply with practice protocols, take part in research that will form the basis of evidence, and follow the results of these studies. The aim of basic oral care is to reduce the effect of oral microbial flora and to prevent opportunistic infections. Basic oral care; It consists of brushing teeth with a soft-bristled toothbrush, cleaning between teeth with dental floss, rinsing the mouth using sterile water, saline or sodium bicarbonate. In basic oral care, it is recommended that the platelet (PLT) number be above 50,000 mm3 and the white blood cell (WBC) count over 1,000 mm3 for brushing and flossing. There is insufficient evidence that any component of basic oral care in the evidence-based practice guidelines fully prevents oral mucositis. However, there is evidence that it reduces the severity and duration of oral mucositis. To prevent and treat mucositis, saline, sodium bicarbonate, granulocyte colony stimulating factor (G-CSF), granulocyte-macrophage colony stimulating factor (GM-CSF), zinc sulfate, cryotherapy, sucralfate suspension, amifostine, prostaglandi E2 (PGE2) ), hydroxypropyl cellulose film, mucous sealants such as polyvinylpyrrolidone/sodium hyaluronate, topical application of vitamins A and E, parenteral application of β-carotene, low-dose laser therapy, glutamine, royal jelly, honey, aloe vera solution, omega-3 fatty acid, andiroba oil, black mulberry molasses and black mulberry syrup are used. In his study in 2020, Chadayan used coconut oil in his oral care to heal oral mucositis, and it was found that rinsing the mouth with coconut oil reduced the degree of oral mucositis. Studies have found that coconut oil has an effect on plaque formation and plaque-related gingivitis. Coconut oil is an edible oil and is consumed as part of the staple diet in many tropical countries. Coconut oil differs from most other dietary fats in that the predominant composition of coconut oil is a medium-chain fatty acid, while the basic building blocks of most other oils are almost entirely long-chain fatty acids. This is the physical and affect its chemical properties. Coconut oil contains 92% saturated acids, about 50% of which is lauric acid. Breast milk is the only other naturally occurring substance that contains such a high concentration of lauric acid. Lauric acid has proven anti-inflammatory effects and antimicrobial effects. These include Candida species and various viruses, including Helicobacter pylori, Staphylococcus aureus, Escherichia vulneris, Enterobcater and Candida glabrata, Candida albicans, Candida stellatoidea, Candida parapsilosis, Candida tropicalis, and Candida krusei. This study was planned to determine the effect of oral care with coconut oil on the degree of oral mucositis in pediatric oncology patients.
- Conditions
- Oral Mucositis
- Being tested
- coconut oil
- Keywords
- oral mucositis, child, cancer, Oral care, Nursing, coconut oil
- Medical subject headings
- Stomatitis, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coconut oilOther
- The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Child Mucositis Evaluation Scale (ChIMES) on days 0, 7, and 14, and after each assessment, the frequency of oral care is determined and applied for 21 days. The final assessment is made on Day 21.
| Study group | Role | What they receive |
|---|---|---|
| No Intervention: Control group | No intervention | * Consent is obtained with an informed consent form. * Patient identification form is filled. * The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Pediatric Mucositis Rating Scale (ChIMES) before receiving chemotherapy. According to the World Health Organization Mucositis Classification, the frequency of oral care is decided. * The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Child Mucositis Evaluation Scale (ChIMES) on days 0, 7, and 14, and after each assessment, the frequency of oral care is determined and applied for 21 days. The final assessment is made on Day 21. * The care given according to the frequency of oral care determined according to the score obtained by the patient in the World Health Organization Mucositis Classification is recorded on the "Basic Oral Care Protocol Follow-up Chart". |
| Experimental: Experimental Group | Experimental | Unlike the control group, the experimental group is rinsed with 5 ml of coconut 4 times a day. Receives: Other: coconut oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
World Health Organization Oral Toxicity Scale
Evaluation of mucositis; It is performed by grading from 0 to 4 degrees according to the presence of erythema, ulceration, edema and pain. In the index, grade 0 indicates no mucositis, grade 1 mild, grade 2 moderate, grade 3-4 severe mucositis.
Measured: 21 day
Children's International Mucositis Evaluation Scale (ChIMES)
- The severity of intraoral pain; 2. The effect of pain on swallowing; 3. The effect of pain on eating; 4. The effect of pain on drinking; 5. The condition and reason for taking painkillers; 6. It consists of 6 items to evaluate the presence/absence of oral ulcers. Items 1, 2, 3 and 4 of ChIMES are each evaluated with a minimum of 0 and a maximum of 5 points; 5. Item is evaluated with a minimum of 0 and a maximum of 2 points; The 6th item is evaluated with the lowest 0 and the highest 1 point. When all items are answered, the minimum score from the scale is "0" and the maximum score is "23".
Measured: 21 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start1 Mar 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled experimental design
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Büşra Ekinci
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Büşra Ekinci, Istanbul University - Cerrahpasa
- Investigators
- Ali Ayçiçek, Prof. Dr., Principal investigator, Başakşehir Çam & Sakura City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05849571
- Sponsor's protocol ID
- E-13022260-199-309276
- Status last verified
- Oct 2023
- First submitted
- 4 Feb 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cakmak S., Nural N. Oral Mucositis in Patients Receiving Chemotherapy and Radiotherapy: A Review. Dokuz Eylul University Faculty of Nursing Electronic Journal. 2020; 13(3): 185-194.
Cavusoglu, H. Evidence-Based Nursing in the Management of Oral Mucositis. Turkiye Klinikleri Journal of Medical Sciences. 2007; 27(3): 398-406.
Erdemir, F. and Taş Arslan, F. Pediatric Nursing: Child with Oncological Problems and Nursing Care. 2018; Ozyurt Publishing, Ankara
Terracini B. Epidemiology of childhood cancer. Environ Health. 2011 Apr 5;10 Suppl 1(Suppl 1):S8. doi: 10.1186/1476-069X-10-S1-S8.
PubMed 21489218Türüner, E.K. and Büyükgönenç, L. Child Health Basic Nursing Approaches. Neyir Publishing. 2017; Ankara.
Yavuz B, Bal Yilmaz H, Karaman N A study of reliability and validity for the Turkish version of children's international mucositisis evaluation scale for children with cancer. Turkish Journal of Oncology. 2011; 26(4): 157-162.
Bayindir, S. The Effect of Oral Care with Black Mulberry Syrup on Oral Mucositis Healing in Individuals with COPD. Erciyes University, Institute of Health Sciences, Department of Nursing. 2018; PhD Thesis, Kayseri
Albayrak, A. The effect of chewing gum with black mulberry syrup on the prevention of oral mucositis in children receiving chemotherapy. 2019; Unpublished master's thesis. Bursa Uludag University Institute of Health Sciences
Baysal, E. The Effect of Cryotherapy on the Prevention of Oral Mucositis in Patients with Multiple Myeloma Diagnosed with Autologous Stem Cell Transplantation. Ege University Institute of Health Sciences, Department of Nursing Fundamentals. 2019; PhD Thesis, İzmir.
Bektaş, M. The effect of planned basic oral care education given to children receiving chemotherapy on the prevention of oral mucositis. 2019; Master Thesis, Karadeniz Technical University, Institute of Health Sciences.
Beşirik, S. & Canbulat Şahiner, N. Evidence-Based Practices in the Management of Mucositis in Children . Gumushane University Journal of Health Sciences. 2018; 7 (4), 128-133. Retrieved from https://dergipark.org.tr/tr/pub/gumussagbil/issue/41325/447904
Chadayan, C. Effectiveness Of Coconut Oil Pulling On Oral Mucositis Among Cancer Patients In a Selected Hospital At Maduari.International Journal of Applied Research in Bioinformatics.2020. Doi:10.6084/m9.figshare.14769189.v1
Devi KS, Allenidekania A. The Relationship of Oral Care Practice at Home with Mucositis Incidence in Children with Acute Lymphoblastic Leukemia. Compr Child Adolesc Nurs. 2019;42(sup1):56-64. doi: 10.1080/24694193.2019.1577926.
PubMed 31192726He M, Zhang B, Shen N, Wu N, Sun J. A systematic review and meta-analysis of the effect of low-level laser therapy (LLLT) on chemotherapy-induced oral mucositis in pediatric and young patients. Eur J Pediatr. 2018 Jan;177(1):7-17. doi: 10.1007/s00431-017-3043-4. Epub 2017 Nov 11.
PubMed 29128883Kobya 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 27912937
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effect of Oral Care With Coconut Oil on the Degree of Oral Mucositis in Pediatric Oncology Patients
- ClinicalTrials.gov ID
- NCT05849571
- Acronym / sponsor ID
- E-13022260-199-309276
- Conditions
- Oral Mucositis
- Keywords
- oral mucositis, child, cancer, Oral care, Nursing, coconut oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Büşra EkinciUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 9 May 2023 (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.
Oral mucositis is characterized by ulcerative and inflammatory changes in the oral mucosa and is frequently seen in pediatric oncology patients receiving chemotherapy. Oral mucositis negatively affects the child's daily life functions, nutrition and quality of life. Pain is the most commonly reported side effect in mucositis. Pain impairs patients' ability to chew, swallow and speak, leading to inadequate fluid/nutrient intake, malnutrition and communication problems. Weight loss, dehydration, mucosal ulceration, fluid-electrolyte imbalance may develop in patients who cannot be fed adequately, and total parenteral nutrition (TPN) can be started. Other important complications of oral mucositis are oral bleeding and infection. The ulcerated oral mucosa creates an entrance gate for microorganisms, increasing the risk of bacterial/fungal/viral infections. Infections may be limited only to the oral mucosa, as well as systemic infection and septicemia. As a result, the length of hospital stay of the patients increases, the treatment costs increase and their quality of life deteriorates. Therefore, early diagnosis of oral mucositis, planning and implementation of oral care are important. Responsibility of nurses in the management of oral mucositis; monitoring the oral cavity for symptoms, diagnosing mucositis, providing appropriate oral care, and educating patients.
In this context, it is extremely important to prevent oral mucositis, to evaluate the oral mucosa using a scale, and to reduce the degree of oral mucositis, that is, to perform appropriate oral care for its recovery, in terms of preventing other health problems and ensuring the well-being of the child. The aim of this thesis is to determine the effect of oral care with coconut oil on the degree of oral mucositis in pediatric oncology patients.
Detailed description
Cancers have an important place among the childhood health problems. Although deaths in childhood cancers have decreased in recent years, it has been reported that the incidence of cancer has increased. Although the incidence of childhood cancers is lower than that of adult cancers, 0.5% of all cancer cases are children under the age of 15. Treatments such as chemotherapy, radiotherapy, surgical treatment, and bone marrow transplantation are applied alone or in combination in cancer treatment. Chemotherapy, which is one of the most used treatment methods in childhood cancers, destroys cancer cells, can prevent the spread of cancer cells in the body and the recurrence of the disease by 60-70%. Chemotherapy can cause complications by affecting normal cells and tissues as well as cancer cells. Among these complications, anemia, alopecia, dermatitis, thrombocytopenia, mucositis, nausea-vomiting and pain are the most common complications. Oral mucositis is one of the most common complications after chemotherapy and is seen in approximately 52% to 80% of children receiving treatment. Oral mucositis can directly affect the individual's quality of life by causing major problems such as shedding of the oral mucosal skin, ulceration, bleeding, pain, bacterial, fungal and viral infections in sick individuals. These problems make it difficult for the child to eat, drink, swallow and speak, and may lead to the development of biopsychosocial problems such as changes in comfort, decrease in body image and self-esteem, and increase in hospitalization time and hospital cost. It is important to prevent and manage mucositis in order to increase the quality of life of these children and reduce their stress levels. Proper oral hygiene and care practices are effective in the prevention and management of mucositis. Oral care provided by nurses is very important. Nurses, who play a primary role in patient care, are responsible for oral care and the prevention of mucositis. In order to prevent the development of mucositis, nurses need to have sufficient knowledge and skills, comply with practice protocols, take part in research that will form the basis of evidence, and follow the results of these studies. The aim of basic oral care is to reduce the effect of oral microbial flora and to prevent opportunistic infections. Basic oral care; It consists of brushing teeth with a soft-bristled toothbrush, cleaning between teeth with dental floss, rinsing the mouth using sterile water, saline or sodium bicarbonate. In basic oral care, it is recommended that the platelet (PLT) number be above 50,000 mm3 and the white blood cell (WBC) count over 1,000 mm3 for brushing and flossing. There is insufficient evidence that any component of basic oral care in the evidence-based practice guidelines fully prevents oral mucositis. However, there is evidence that it reduces the severity and duration of oral mucositis. To prevent and treat mucositis, saline, sodium bicarbonate, granulocyte colony stimulating factor (G-CSF), granulocyte-macrophage colony stimulating factor (GM-CSF), zinc sulfate, cryotherapy, sucralfate suspension, amifostine, prostaglandi E2 (PGE2) ), hydroxypropyl cellulose film, mucous sealants such as polyvinylpyrrolidone/sodium hyaluronate, topical application of vitamins A and E, parenteral application of β-carotene, low-dose laser therapy, glutamine, royal jelly, honey, aloe vera solution, omega-3 fatty acid, andiroba oil, black mulberry molasses and black mulberry syrup are used. In his study in 2020, Chadayan used coconut oil in his oral care to heal oral mucositis, and it was found that rinsing the mouth with coconut oil reduced the degree of oral mucositis. Studies have found that coconut oil has an effect on plaque formation and plaque-related gingivitis. Coconut oil is an edible oil and is consumed as part of the staple diet in many tropical countries. Coconut oil differs from most other dietary fats in that the predominant composition of coconut oil is a medium-chain fatty acid, while the basic building blocks of most other oils are almost entirely long-chain fatty acids. This is the physical and affect its chemical properties. Coconut oil contains 92% saturated acids, about 50% of which is lauric acid. Breast milk is the only other naturally occurring substance that contains such a high concentration of lauric acid. Lauric acid has proven anti-inflammatory effects and antimicrobial effects. These include Candida species and various viruses, including Helicobacter pylori, Staphylococcus aureus, Escherichia vulneris, Enterobcater and Candida glabrata, Candida albicans, Candida stellatoidea, Candida parapsilosis, Candida tropicalis, and Candida krusei. This study was planned to determine the effect of oral care with coconut oil on the degree of oral mucositis in pediatric oncology patients.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled experimental design
| Arm | Type | Receives |
|---|---|---|
| No Intervention: Control group | No intervention | –* Consent is obtained with an informed consent form. * Patient identification form is filled. * The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Pediatric Mucositis Rating Scale (ChIMES) before receiving chemotherapy. According to the World Health Organization Mucositis Classification, the frequency of oral care is decided. * The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Child Mucositis Evaluation Scale (ChIMES) on days 0, 7, and 14, and after each assessment, the frequency of oral care is determined and applied for 21 days. The final assessment is made on Day 21. * The care given according to the frequency of oral care determined according to the score obtained by the patient in the World Health Organization Mucositis Classification is recorded on the "Basic Oral Care Protocol Follow-up Chart". |
| Experimental: Experimental Group | Experimental | Other: coconut oilUnlike the control group, the experimental group is rinsed with 5 ml of coconut 4 times a day. |
Who may qualify
- Ages
- 7 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Being between 7-18 years old,
- Having been diagnosed with cancer,
- Receiving chemotherapy at least every 21 or 28 days,
- Willingness and volunteering to participate in the study,
- Being able to speak Turkish and express himself
Key exclusion criteria (5 listed)
- Not being healthy inside the mouth before chemotherapy,
- Being in terminal period,
- Being receiving radiotherapy
- Not willing or voluntarily to participate in the study,
- Not knowing Turkish.
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 |
|---|---|---|
| coconut oil• The patient's mouth is evaluated using the World Health Organization Mucositis Classification and the International Child Mucositis Evaluation Scale (ChIMES) on days 0, 7, and 14, and after each assessment, the frequency of oral care is determined and applied for 21 days. The final assessment is made on Day 21. | Other | Experimental: Experimental Group |
Primary outcome
World Health Organization Oral Toxicity Scale
Time frame: 21 day
Evaluation of mucositis; It is performed by grading from 0 to 4 degrees according to the presence of erythema, ulceration, edema and pain. In the index, grade 0 indicates no mucositis, grade 1 mild, grade 2 moderate, grade 3-4 severe mucositis.
Children's International Mucositis Evaluation Scale (ChIMES)
Time frame: 21 day
1. The severity of intraoral pain; 2. The effect of pain on swallowing; 3. The effect of pain on eating; 4. The effect of pain on drinking; 5. The condition and reason for taking painkillers; 6. It consists of 6 items to evaluate the presence/absence of oral ulcers. Items 1, 2, 3 and 4 of ChIMES are each evaluated with a minimum of 0 and a maximum of 5 points; 5. Item is evaluated with a minimum of 0 and a maximum of 2 points; The 6th item is evaluated with the lowest 0 and the highest 1 point. When all items are answered, the minimum score from the scale is "0" and the maximum score is "23".
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 4 Oct 2023.
- BackgroundCakmak S., Nural N. Oral Mucositis in Patients Receiving Chemotherapy and Radiotherapy: A Review. Dokuz Eylul University Faculty of Nursing Electronic Journal. 2020; 13(3): 185-194.
- BackgroundCavusoglu, H. Evidence-Based Nursing in the Management of Oral Mucositis. Turkiye Klinikleri Journal of Medical Sciences. 2007; 27(3): 398-406.
- BackgroundErdemir, F. and Taş Arslan, F. Pediatric Nursing: Child with Oncological Problems and Nursing Care. 2018; Ozyurt Publishing, Ankara
- Background: PubMed 21489218Terracini B. Epidemiology of childhood cancer. Environ Health. 2011 Apr 5;10 Suppl 1(Suppl 1):S8. doi: 10.1186/1476-069X-10-S1-S8.
- BackgroundTürüner, E.K. and Büyükgönenç, L. Child Health Basic Nursing Approaches. Neyir Publishing. 2017; Ankara.
- BackgroundYavuz B, Bal Yilmaz H, Karaman N A study of reliability and validity for the Turkish version of children's international mucositisis evaluation scale for children with cancer. Turkish Journal of Oncology. 2011; 26(4): 157-162.
- Results publicationBayindir, S. The Effect of Oral Care with Black Mulberry Syrup on Oral Mucositis Healing in Individuals with COPD. Erciyes University, Institute of Health Sciences, Department of Nursing. 2018; PhD Thesis, Kayseri
- Results publicationAlbayrak, A. The effect of chewing gum with black mulberry syrup on the prevention of oral mucositis in children receiving chemotherapy. 2019; Unpublished master's thesis. Bursa Uludag University Institute of Health Sciences
- Results publicationBaysal, E. The Effect of Cryotherapy on the Prevention of Oral Mucositis in Patients with Multiple Myeloma Diagnosed with Autologous Stem Cell Transplantation. Ege University Institute of Health Sciences, Department of Nursing Fundamentals. 2019; PhD Thesis, İzmir.
- Results publicationBektaş, M. The effect of planned basic oral care education given to children receiving chemotherapy on the prevention of oral mucositis. 2019; Master Thesis, Karadeniz Technical University, Institute of Health Sciences.
- Results publicationBeşirik, S. & Canbulat Şahiner, N. Evidence-Based Practices in the Management of Mucositis in Children . Gumushane University Journal of Health Sciences. 2018; 7 (4), 128-133. Retrieved from https://dergipark.org.tr/tr/pub/gumussagbil/issue/41325/447904
- Results publicationChadayan, C. Effectiveness Of Coconut Oil Pulling On Oral Mucositis Among Cancer Patients In a Selected Hospital At Maduari.International Journal of Applied Research in Bioinformatics.2020. Doi:10.6084/m9.figshare.14769189.v1
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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.
Ali Ayçiçek, Prof. Dr. principal investigator
Başakşehir Çam & Sakura City Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing coconut oil in people with Oral Mucositis, run by Büşra Ekinci 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 5 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 4 Oct 2023. 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?
World Health Organization Oral Toxicity Scale (time frame: 21 day). The study lists 2 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 NCT05849571, which also lists 27 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 4 Oct 2023.