Leukemia, LymphoblasticNCT04968860
Oral Health Condition and Quality of Life in Children With Leukemia
An observational study of Leukemia, Lymphoblastic and Leukemia, Myeloid, Acute, run by Paulo Sergio da Silva Santos at 1 site in Brazil.
Trial summary
Among the different types of cancer that most affect children, leukemia is the principal. One of the main treatments for leukemia is chemotherapy. Among the most common side effects of chemotherapy are nausea and/or vomiting, diarrhea, fatigue, alopecia, neuropathy, opportunistic infections, and oral mucositis. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Leukemia, Lymphoblastic, Leukemia, Myeloid, Acute
- What is being tested?
- This study is observational
- Type of treatment
- Pill or oral medicine
- How many people
- 9 participants
- Where
- 1 siteBrazil
- Study dates
- 1 Sep 2019to 17 Dec 2022
- How long will I take part?
- 6 Months
- Phase
- Observational
- 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 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: The study group will be composed of children/adolescent individuals who have a definitive diagnosis of lymphoid leukemia or acute myeloid leukemia, who will be invited to participate in the research, regardless of race or gender.
Who may be able to join
- Patients who, based on the agreement of parents and/or guardians, agree to participate in the research with a signed "Informed Consent Form"
- Patients from 3 to 17 years of age
- Patients older than 6 years must not only have parental and/or guardian authorization must have the consent term
- Patients who have not started antineoplastic treatment
- Patients with ALL only with BFM protocol
- AML patients with BFM protocol only
Who cannot join
- Responsible for patients who do not sign the free and informed consent form.
- Patients under three years of age and over 17 years of age
- Children older than six years who do not agree to the term of assent
- Patients who have started antineoplastic treatment
- Patients with syndromes and/or other systemic diseases associated with the diagnosis of lymphoid and acute myeloid leukemia
- Neoplasms other than lymphoid leukemia or acute myeloid
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Faculdade de Odontologia de Bauru, Universidade de São Paulo
Bauru, São Paulo, 17012-901
About this study
Official title: Clinical-microbiological Study of Oral Health Condition and Quality of Life of Children/Adolescent With Acute Lymphoid Leukemia and Acute Myeloid
Among the different types of cancer that most affect children, leukemia is the principal. One of the main treatments for leukemia is chemotherapy. Among the most common side effects of chemotherapy are nausea and/or vomiting, diarrhea, fatigue, alopecia, neuropathy, opportunistic infections, and oral mucositis. It is still necessary to establish which microorganisms are predominant in the oral microbiota of children with leukemia, which factors influence it, what is its relationship with oral mucositis and what is their impact in the quality of life. To better understand the risks of secondary infection, it is important to develop preventive and/or therapeutic strategies to control the side effects of antineoplastic treatment in the mouth that may negatively impact the quality of life, to expose the risk of death as well as raise hospital costs for the care of children with leukemia. Objective: To identify the clinical characteristics of the oral condition, types of microorganisms of the oral microbiota, and quality of life in children/adolescents with acute lymphoid leukemia and acute myeloid leukemia before and during antineoplastic treatment, and compare them with healthy children/adolescent individuals. Methodology: Longitudinal, case-control study, with a convenience sample. The study group, composed of children/adolescent individuals who have a definitive diagnosis of acute lymphoid leukemia or acute myeloid leukemia. The control group, non-syndromic children/adolescents, with no history of cancer, matched by age and gender. The clinical condition of the mouth will be evaluated by means of indexes: dental caries index (dmft index), gingival index (GA), and simplified oral hygiene index. The assessment of the quality of life through the ohip-14 and POS-version14 quality of life questionnaire and microbiological evaluation of saliva through MALDI-TOF analysis. Statistical analysis will be performed through relative risk for cohort study with more than three paired groups. Odds ratio, for the control group more than three controlled groups and Mcnemere, for comparison with the control group, for more than three paired groups.
Read the detailed description
In children, non-communicable diseases such as cancer are increasing every year. It became a priority on the global child health agenda. Each year, there were an estimated 30.000 new cases of cancer in children/adolescent individuals. In Brazil, between 2018-2019, there were 12.500 new cases of cancer in children and adolescents up to 19 years of age. The mortality rate was 7.917 cases.
Among the types of cancer that most affect children, leukemia is the most prevalent. In 2018, there was a forecast of 437.033 new cases of leukemia with a mortality of 309.006 individuals around the world.
One of the main treatments for leukemia is chemotherapy, the side effects can affect different parts of the body that may present since the beginning of the treatment. Chemotherapy produces systemic toxicity resulting in anemia, leukopenia, and thrombocytopenia that is more intense in the treatment of oncohematological diseases when compared to solid tumors. Among the most common side effects of chemotherapy are included nausea and/or vomiting, diarrhea, fatigue, alopecia, neuropathy, opportunistic infections, and oral mucositis.
Some studies reported that the intensity of oral mucositis, as well as the risk of sepsis from secondary infection in the mouth of individuals with cancer, they can be influenced by some specific microorganisms present in the oral cavity. Factors such as oral hygiene, presence of dental caries, and periodontal disease may be related to the type of microorganisms present in the oral cavity. There is a lack of studies about microbiota oral in leukemic children. Oral microbiota in children with leukemia is predominantly composed of gram-positive microorganisms such as Streptococus viridans, Streptococous mutans and Lactobacillus when compared to adults oral microbiota where gram-negatives microorganisms such as Klebsiella spp., E coli, Enterobacter, Pseudomonas spp. predominate. It is noteworthy that it is necessary to establish what kind of microorganisms are predominant in the oral microbiota of children with leukemia, also which factors influence it, and what is the relationship among the oral mucositis, general clinical status, and quality of life of the children/adolescent with cancer.
Therefore, it is important to identify the risks of secondary infection in oral cavity, to be able to develop preventive and/or therapeutic strategies to control the side effects of antineoplastic treatment in the mouth that can negatively impact the quality of life, expose the risk of death as well as raise hospital costs for the care of children with leukemia.
- Conditions
- Leukemia, Lymphoblastic, Leukemia, Myeloid, Acute
- Being tested
- This study is observational
- Keywords
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Microbiota, Mouth, Quality of life, Children
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
This study is observationalOther
- Clinical evaluation of the oral health condition
- Microbiota evaluation by analyzing the collected saliva
- Application of questionnaires of quality of life
| Study group | Role | What they receive |
|---|---|---|
| Study group | Composed of children/adolescent individuals who have a definitive diagnosis of lymphoid leukemia or acute myeloid leukemia, who will be invited to participate in the research, regardless of race or gender. Receives: Other: This study is observational | |
| Control group | The control group is going to consist of healthy children/adolescent individuals, non-syndromic, without history of cancer, matched by age and gender in relation to the study group, who have not used antibiotics 48 hours before or in the day of evaluation. Receives: Other: This study is observational |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of dental condition
Dental condition is going to be evaluated by dental caries index (dmft index) (WHO, 2013).
Measured: 5 minutes to 10 minutes
Evalulation of periodontal condition
The periodontal evaluation it is goning to be evaluated by and gingival index (LOE, 1964)
Measured: 10 minutes to 15 minutes
Evalulation of oral hygiene
Oral hygiene is going to be evaluated by simplified oral hygiene index (IHO-S).
Measured: 10 minutes to 15 minutes
To evaluate oral mucositis
the presence of oral mucositis will be evaluated through the graduation recommended by the World Health Organization (WHO) (WHO, 1979).
Measured: 5 minutes to 10 minutes
Evaluation of oral pain of oral mucositis
The oral pain because of the oral mucositis is going to be evaluated by Visual Analogue Scael of pain and it is gonig to be scaled by the Wong-Backer face scale which is from 0 to 10 pontuation, being 1 the minimium pain percivied and 10 de maximium pain percieved. This evaluation it is going to be make only in children with leukemia.
Measured: 1 minutes to 2 minutes
Saliva collection
The collection of the saliva is going to be made by an unstimulated technic. The minimum of 2 mL to maximum of 10 ml of saliva are going to be collected.
Measured: 15 minutes to 20 minutes
to evaluate the quality of life of children percieved by parents
A Pediatric Quality of Life Inventory Version 4.0 questionaire is going to be answered by children parentes with the following five options: never = 0, almost never = 1, sometimes = 2, often = 3, and almost always = 4.
Measured: 10 to 15 minutes
to evaluate the impact of oral condition on the quality of life percieved by the children
A OHIP-14 (Oral Health Impact Profile) questionnaire (adapted for children) is going to be applied to children with 6 years old or children older than 6 years old. The questionaire is going to be answered with five options: never = 0, almost never =1 , sometimes = 2, often = 3, and almost always = 4 which is represented by a face scale.
Measured: 10 to 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2021
- Study start1 Sep 2019
- Primary completion8 Jul 2021
- Study completion17 Dec 2022
Why it stopped: Low casuistry that did not allow the study to continue
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Leukemia, LymphoblasticStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 9 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Paulo Sergio da Silva Santos
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Paulo Sergio da Silva Santos, University of Sao Paulo
- Investigators
- Reyna A Quispe, MsC, Principal investigator, Faculdade de Odontologia de Bauru, Universidade de São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04968860
- Sponsor's protocol ID
- LEUKEMIARAQ
- Status last verified
- Mar 2024
- First submitted
- 3 Jun 2020
- Last updated
- 8 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Steliarova-Foucher E, Fidler MM, Colombet M, Lacour B, Kaatsch P, Pineros M, Soerjomataram I, Bray F, Coebergh JW, Peris-Bonet R, Stiller CA; ACCIS contributors. Changing geographical patterns and trends in cancer incidence in children and adolescents in Europe, 1991-2010 (Automated Childhood Cancer Information System): a population-based study. Lancet Oncol. 2018 Sep;19(9):1159-1169. doi: 10.1016/S1470-2045(18)30423-6. Epub 2018 Aug 8.
PubMed 30098952Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
PubMed 30207593Carlotto A, Hogsett VL, Maiorini EM, Razulis JG, Sonis ST. The economic burden of toxicities associated with cancer treatment: review of the literature and analysis of nausea and vomiting, diarrhoea, oral mucositis and fatigue. Pharmacoeconomics. 2013 Sep;31(9):753-66. doi: 10.1007/s40273-013-0081-2.
PubMed 23963867Ozdemir ZC, Bozkurt Turhan A, Duzenli Kar Y, Dinleyici CE, Bor O. Fatal course of Saprochaete capitata fungemia in children with acute lymphoblastic leukemia. Pediatr Hematol Oncol. 2017 Mar;34(2):66-72. doi: 10.1080/08880018.2017.1316808. Epub 2017 Jun 2.
PubMed 28574735Damascena LCL, de Lucena NNN, Ribeiro ILA, de Araujo TLP, de Castro RD, Bonan PRF, Lima Neto EA, de Araujo Filho LM, Valenca AMG. Factors Contributing to the Duration of Chemotherapy-Induced Severe Oral Mucositis in Oncopediatric Patients. Int J Environ Res Public Health. 2018 Jun 1;15(6):1153. doi: 10.3390/ijerph15061153.
PubMed 29865201Napenas JJ, Brennan MT, Bahrani-Mougeot FK, Fox PC, Lockhart PB. Relationship between mucositis and changes in oral microflora during cancer chemotherapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Jan;103(1):48-59. doi: 10.1016/j.tripleo.2005.12.016. Epub 2006 Apr 21.
PubMed 17178494Santos de Faria AB, Silva IH, de Godoy Almeida R, Silva SP, Carvalho AT, Leao JC. Seroprevalence of herpes virus associated with the presence and severity of oral mucositis in children diagnosed with acute lymphoid leukemia. J Oral Pathol Med. 2014 Apr;43(4):298-303. doi: 10.1111/jop.12138. Epub 2013 Dec 10.
PubMed 24325331O'Sullivan EA, Duggal MS, Bailey CC, Curzon ME, Hart P. Changes in the oral microflora during cytotoxic chemotherapy in children being treated for acute leukemia. Oral Surg Oral Med Oral Pathol. 1993 Aug;76(2):161-8. doi: 10.1016/0030-4220(93)90198-d.
PubMed 8361725Volpato LE, Kloster AP, Nunes LF, Pedro FL, Borges AH. Cariogenic microbiota of children under chemotherapy: A pilot study. J Indian Soc Pedod Prev Dent. 2016 Oct-Dec;34(4):370-6. doi: 10.4103/0970-4388.191423.
PubMed 27681402Valera MC, Noirrit-Esclassan E, Pasquet M, Vaysse F. Oral complications and dental care in children with acute lymphoblastic leukaemia. J Oral Pathol Med. 2015 Aug;44(7):483-9. doi: 10.1111/jop.12266. Epub 2014 Sep 22.
PubMed 25243950Wang Y, Xue J, Zhou X, You M, Du Q, Yang X, He J, Zou J, Cheng L, Li M, Li Y, Zhu Y, Li J, Shi W, Xu X. Oral microbiota distinguishes acute lymphoblastic leukemia pediatric hosts from healthy populations. PLoS One. 2014 Jul 15;9(7):e102116. doi: 10.1371/journal.pone.0102116. eCollection 2014.
PubMed 25025462Villafuerte KRV, Martinez CJH, Dantas FT, Carrara HHA, Dos Reis FJC, Palioto DB. The impact of chemotherapeutic treatment on the oral microbiota of patients with cancer: a systematic review. Oral Surg Oral Med Oral Pathol Oral Radiol. 2018 Jun;125(6):552-566. doi: 10.1016/j.oooo.2018.02.008. Epub 2018 Feb 21.
PubMed 29566996Bardellini E, Amadori F, Majorana A. Oral hygiene grade and quality of life in children with chemotherapy-related oral mucositis: a randomized study on the impact of a fluoride toothpaste with salivary enzymes, essential oils, proteins and colostrum extract versus a fluoride toothpaste without menthol. Int J Dent Hyg. 2016 Nov;14(4):314-319. doi: 10.1111/idh.12226. Epub 2016 May 10.
PubMed 27160933Grando LJ, Mello ALSF, Salvato L, Brancher AP, Del Moral JAG, Steffenello-Durigon G. Impact of leukemia and lymphoma chemotherapy on oral cavity and quality of life. Spec Care Dentist. 2015 Sep;35(5):236-242. doi: 10.1111/scd.12113. Epub 2015 May 12.
PubMed 25963973
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical-microbiological Study of Oral Health Condition and Quality of Life of Children/Adolescent With Acute Lymphoid Leukemia and Acute Myeloid
- ClinicalTrials.gov ID
- NCT04968860
- Acronym / sponsor ID
- LEUKEMIARAQ
- Conditions
- Leukemia, Lymphoblastic, Leukemia, Myeloid, Acute
- Keywords
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Microbiota, Mouth, Quality of life, Children
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low casuistry that did not allow the study to continue
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Paulo Sergio da Silva SantosUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 8 Jul 2021 (actual)
- Study completion
- 17 Dec 2022 (actual)
- First posted
- 20 Jul 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.
Among the different types of cancer that most affect children, leukemia is the principal. One of the main treatments for leukemia is chemotherapy. Among the most common side effects of chemotherapy are nausea and/or vomiting, diarrhea, fatigue, alopecia, neuropathy, opportunistic infections, and oral mucositis. It is still necessary to establish which microorganisms are predominant in the oral microbiota of children with leukemia, which factors influence it, what is its relationship with oral mucositis and what is their impact in the quality of life. To better understand the risks of secondary infection, it is important to develop preventive and/or therapeutic strategies to control the side effects of antineoplastic treatment in the mouth that may negatively impact the quality of life, to expose the risk of death as well as raise hospital costs for the care of children with leukemia. Objective: To identify the clinical characteristics of the oral condition, types of microorganisms of the oral microbiota, and quality of life in children/adolescents with acute lymphoid leukemia and acute myeloid leukemia before and during antineoplastic treatment, and compare them with healthy children/adolescent individuals. Methodology: Longitudinal, case-control study, with a convenience sample. The study group, composed of children/adolescent individuals who have a definitive diagnosis of acute lymphoid leukemia or acute myeloid leukemia. The control group, non-syndromic children/adolescents, with no history of cancer, matched by age and gender. The clinical condition of the mouth will be evaluated by means of indexes: dental caries index (dmft index), gingival index (GA), and simplified oral hygiene index. The assessment of the quality of life through the ohip-14 and POS-version14 quality of life questionnaire and microbiological evaluation of saliva through MALDI-TOF analysis. Statistical analysis will be performed through relative risk for cohort study with more than three paired groups. Odds ratio, for the control group more than three controlled groups and Mcnemere, for comparison with the control group, for more than three paired groups.
Detailed description
In children, non-communicable diseases such as cancer are increasing every year. It became a priority on the global child health agenda. Each year, there were an estimated 30.000 new cases of cancer in children/adolescent individuals. In Brazil, between 2018-2019, there were 12.500 new cases of cancer in children and adolescents up to 19 years of age. The mortality rate was 7.917 cases.
Among the types of cancer that most affect children, leukemia is the most prevalent. In 2018, there was a forecast of 437.033 new cases of leukemia with a mortality of 309.006 individuals around the world.
One of the main treatments for leukemia is chemotherapy, the side effects can affect different parts of the body that may present since the beginning of the treatment. Chemotherapy produces systemic toxicity resulting in anemia, leukopenia, and thrombocytopenia that is more intense in the treatment of oncohematological diseases when compared to solid tumors. Among the most common side effects of chemotherapy are included nausea and/or vomiting, diarrhea, fatigue, alopecia, neuropathy, opportunistic infections, and oral mucositis.
Some studies reported that the intensity of oral mucositis, as well as the risk of sepsis from secondary infection in the mouth of individuals with cancer, they can be influenced by some specific microorganisms present in the oral cavity. Factors such as oral hygiene, presence of dental caries, and periodontal disease may be related to the type of microorganisms present in the oral cavity. There is a lack of studies about microbiota oral in leukemic children. Oral microbiota in children with leukemia is predominantly composed of gram-positive microorganisms such as Streptococus viridans, Streptococous mutans and Lactobacillus when compared to adults oral microbiota where gram-negatives microorganisms such as Klebsiella spp., E coli, Enterobacter, Pseudomonas spp. predominate. It is noteworthy that it is necessary to establish what kind of microorganisms are predominant in the oral microbiota of children with leukemia, also which factors influence it, and what is the relationship among the oral mucositis, general clinical status, and quality of life of the children/adolescent with cancer.
Therefore, it is important to identify the risks of secondary infection in oral cavity, to be able to develop preventive and/or therapeutic strategies to control the side effects of antineoplastic treatment in the mouth that can negatively impact the quality of life, expose the risk of death as well as raise hospital costs for the care of children with leukemia.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Other: This study is observationalComposed of children/adolescent individuals who have a definitive diagnosis of lymphoid leukemia or acute myeloid leukemia, who will be invited to participate in the research, regardless of race or gender. |
| Control group | – | Other: This study is observationalThe control group is going to consist of healthy children/adolescent individuals, non-syndromic, without history of cancer, matched by age and gender in relation to the study group, who have not used antibiotics 48 hours before or in the day of evaluation. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- The study group will be composed of children/adolescent individuals who have a definitive diagnosis of lymphoid leukemia or acute myeloid leukemia, who will be invited to participate in the research, regardless of race or gender.
Key inclusion criteria (6 listed)
- Patients who, based on the agreement of parents and/or guardians, agree to participate in the research with a signed "Informed Consent Form"
- Patients from 3 to 17 years of age
- Patients older than 6 years must not only have parental and/or guardian authorization must have the consent term
- Patients who have not started antineoplastic treatment
- Patients with ALL only with BFM protocol
Key exclusion criteria (6 listed)
- Responsible for patients who do not sign the free and informed consent form.
- Patients under three years of age and over 17 years of age
- Children older than six years who do not agree to the term of assent
- Patients who have started antineoplastic treatment
- Patients with syndromes and/or other systemic diseases associated with the diagnosis of lymphoid and acute myeloid leukemia
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 |
|---|---|---|
| This study is observational* Clinical evaluation of the oral health condition * Microbiota evaluation by analyzing the collected saliva * Application of questionnaires of quality of life | Other | Control group, Study group |
Primary outcome
Evaluation of dental condition
Time frame: 5 minutes to 10 minutes
Dental condition is going to be evaluated by dental caries index (dmft index) (WHO, 2013).
Evalulation of periodontal condition
Time frame: 10 minutes to 15 minutes
The periodontal evaluation it is goning to be evaluated by and gingival index (LOE, 1964)
Evalulation of oral hygiene
Time frame: 10 minutes to 15 minutes
Oral hygiene is going to be evaluated by simplified oral hygiene index (IHO-S).
To evaluate oral mucositis
Time frame: 5 minutes to 10 minutes
the presence of oral mucositis will be evaluated through the graduation recommended by the World Health Organization (WHO) (WHO, 1979).
Evaluation of oral pain of oral mucositis
Time frame: 1 minutes to 2 minutes
The oral pain because of the oral mucositis is going to be evaluated by Visual Analogue Scael of pain and it is gonig to be scaled by the Wong-Backer face scale which is from 0 to 10 pontuation, being 1 the minimium pain percivied and 10 de maximium pain percieved. This evaluation it is going to be make only in children with leukemia.
Saliva collection
Time frame: 15 minutes to 20 minutes
The collection of the saliva is going to be made by an unstimulated technic. The minimum of 2 mL to maximum of 10 ml of saliva are going to be collected.
to evaluate the quality of life of children percieved by parents
Time frame: 10 to 15 minutes
A Pediatric Quality of Life Inventory Version 4.0 questionaire is going to be answered by children parentes with the following five options: never = 0, almost never = 1, sometimes = 2, often = 3, and almost always = 4.
to evaluate the impact of oral condition on the quality of life percieved by the children
Time frame: 10 to 15 minutes
A OHIP-14 (Oral Health Impact Profile) questionnaire (adapted for children) is going to be applied to children with 6 years old or children older than 6 years old. The questionaire is going to be answered with five options: never = 0, almost never =1 , sometimes = 2, often = 3, and almost always = 4 which is represented by a face scale.
Results and safety
The study was stopped early (reason given: Low casuistry that did not allow the study to continue). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Background: PubMed 30098952Steliarova-Foucher E, Fidler MM, Colombet M, Lacour B, Kaatsch P, Pineros M, Soerjomataram I, Bray F, Coebergh JW, Peris-Bonet R, Stiller CA; ACCIS contributors. Changing geographical patterns and trends in cancer incidence in children and adolescents in Europe, 1991-2010 (Automated Childhood Cancer Information System): a population-based study. Lancet Oncol. 2018 Sep;19(9):1159-1169. doi: 10.1016/S1470-2045(18)30423-6. Epub 2018 Aug 8.
- Background: PubMed 30207593Bray F, Ferlay J, Soerjomataram I, Siegel RL, Torre LA, Jemal A. Global cancer statistics 2018: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin. 2018 Nov;68(6):394-424. doi: 10.3322/caac.21492. Epub 2018 Sep 12.
- Background: PubMed 23963867Carlotto A, Hogsett VL, Maiorini EM, Razulis JG, Sonis ST. The economic burden of toxicities associated with cancer treatment: review of the literature and analysis of nausea and vomiting, diarrhoea, oral mucositis and fatigue. Pharmacoeconomics. 2013 Sep;31(9):753-66. doi: 10.1007/s40273-013-0081-2.
- Background: PubMed 28574735Ozdemir ZC, Bozkurt Turhan A, Duzenli Kar Y, Dinleyici CE, Bor O. Fatal course of Saprochaete capitata fungemia in children with acute lymphoblastic leukemia. Pediatr Hematol Oncol. 2017 Mar;34(2):66-72. doi: 10.1080/08880018.2017.1316808. Epub 2017 Jun 2.
- Background: PubMed 29865201Damascena LCL, de Lucena NNN, Ribeiro ILA, de Araujo TLP, de Castro RD, Bonan PRF, Lima Neto EA, de Araujo Filho LM, Valenca AMG. Factors Contributing to the Duration of Chemotherapy-Induced Severe Oral Mucositis in Oncopediatric Patients. Int J Environ Res Public Health. 2018 Jun 1;15(6):1153. doi: 10.3390/ijerph15061153.
- Background: PubMed 17178494Napenas JJ, Brennan MT, Bahrani-Mougeot FK, Fox PC, Lockhart PB. Relationship between mucositis and changes in oral microflora during cancer chemotherapy. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2007 Jan;103(1):48-59. doi: 10.1016/j.tripleo.2005.12.016. Epub 2006 Apr 21.
- Background: PubMed 24325331Santos de Faria AB, Silva IH, de Godoy Almeida R, Silva SP, Carvalho AT, Leao JC. Seroprevalence of herpes virus associated with the presence and severity of oral mucositis in children diagnosed with acute lymphoid leukemia. J Oral Pathol Med. 2014 Apr;43(4):298-303. doi: 10.1111/jop.12138. Epub 2013 Dec 10.
- Background: PubMed 8361725O'Sullivan EA, Duggal MS, Bailey CC, Curzon ME, Hart P. Changes in the oral microflora during cytotoxic chemotherapy in children being treated for acute leukemia. Oral Surg Oral Med Oral Pathol. 1993 Aug;76(2):161-8. doi: 10.1016/0030-4220(93)90198-d.
- Background: PubMed 27681402Volpato LE, Kloster AP, Nunes LF, Pedro FL, Borges AH. Cariogenic microbiota of children under chemotherapy: A pilot study. J Indian Soc Pedod Prev Dent. 2016 Oct-Dec;34(4):370-6. doi: 10.4103/0970-4388.191423.
- Background: PubMed 25243950Valera MC, Noirrit-Esclassan E, Pasquet M, Vaysse F. Oral complications and dental care in children with acute lymphoblastic leukaemia. J Oral Pathol Med. 2015 Aug;44(7):483-9. doi: 10.1111/jop.12266. Epub 2014 Sep 22.
- Background: PubMed 25025462Wang Y, Xue J, Zhou X, You M, Du Q, Yang X, He J, Zou J, Cheng L, Li M, Li Y, Zhu Y, Li J, Shi W, Xu X. Oral microbiota distinguishes acute lymphoblastic leukemia pediatric hosts from healthy populations. PLoS One. 2014 Jul 15;9(7):e102116. doi: 10.1371/journal.pone.0102116. eCollection 2014.
- Background: PubMed 29566996Villafuerte KRV, Martinez CJH, Dantas FT, Carrara HHA, Dos Reis FJC, Palioto DB. The impact of chemotherapeutic treatment on the oral microbiota of patients with cancer: a systematic review. Oral Surg Oral Med Oral Pathol Oral Radiol. 2018 Jun;125(6):552-566. doi: 10.1016/j.oooo.2018.02.008. Epub 2018 Feb 21.
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Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
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.
Reyna A Quispe, MsC principal investigator
Faculdade de Odontologia de Bauru, Universidade de São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, Lymphoblastic and Leukemia, Myeloid, Acute, run by Paulo Sergio da Silva Santos at 1 site in Brazil.
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 6 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: stopped early, as of the sponsor's last update on 8 Mar 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 Brazil. 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 was stopped early (reason given: Low casuistry that did not allow the study to continue). Results are not available in the source record.
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?
Evaluation of dental condition (time frame: 5 minutes to 10 minutes). 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 NCT04968860, which also lists 14 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 8 Mar 2024.