Oral Health Condition and Quality of Life in Children With Leukemia
NCT ID: NCT04968860
Last Updated: 2024-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
9 participants
OBSERVATIONAL
2019-09-01
2022-12-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Oral Manifestations in Children With Cancer
NCT02662465
Laser Therapy Effect on Oral Mucositis in Childhood Acute Lymphoblastic Leukemia Patients
NCT05452668
The Effect of Oral Care Protocol on Prevention of Oral Mucositis in Pediatric Cancer Patients
NCT04586491
Comparison of Prophylactic Photobiomodulation Protocols in Chemoinduced Oral Mucositis in Oncology Patients
NCT05811195
Chemotherapy Oral Manifestations and Dental Awareness Among Parents
NCT05224882
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
Exclusion Criteria
* 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
3 Years
17 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Paulo Sergio da Silva Santos
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Paulo Sergio da Silva Santos
Associate Professor of the Department of Surgery, Stomatology, Pathology and Radiology - Bauru School of Dentistry - University of São Paulo
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Reyna A Quispe, MsC
Role: PRINCIPAL_INVESTIGATOR
Faculdade de Odontologia de Bauru, Universidade de São Paulo
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Faculdade de Odontologia de Bauru, Universidade de São Paulo
Bauru, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Bray 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.
Carlotto 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.
Ozdemir 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.
Damascena 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.
Napenas 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.
Santos 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.
O'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.
Volpato 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.
Valera 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.
Wang 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.
Villafuerte 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.
Bardellini 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.
Grando 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
LEUKEMIARAQ
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.