Oral Health Condition and Quality of Life in Children With Leukemia

NCT04968860 | Terminated

• 1 other identifier: LEUKEMIARAQ
• Study Type: observational
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Leukemia, Lymphoblastic; Leukemia, Myeloid, Acute

Keywords

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute; Microbiota; Mouth; Quality of life; Children

Outcome Measures

Primary Outcomes (8)

• Evaluation of dental condition

  Dental condition is going to be evaluated by dental caries index (dmft index) (WHO, 2013).

  5 minutes to 10 minutes

• Evalulation of periodontal condition

  The periodontal evaluation it is goning to be evaluated by and gingival index (LOE, 1964)

  10 minutes to 15 minutes

• Evalulation of oral hygiene

  Oral hygiene is going to be evaluated by simplified oral hygiene index (IHO-S).

  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).

  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.

  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.

  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.

  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.

  10 to 15 minutes

Study Arms (2)

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.

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.

Other: This study is observational

Interventions

This study is observational OTHER

* Clinical evaluation of the oral health condition * Microbiota evaluation by analyzing the collected saliva * Application of questionnaires of quality of life

Control group; Study group

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Paulo Sergio da Silva Santos: lead

Study Sites (1)

Faculdade de Odontologia de Bauru, Universidade de São Paulo

Bauru, São Paulo, 17012-901, Brazil

Location

Related Publications (14)

• 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.

  PMID: 30098952 BACKGROUND

• 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.

  PMID: 30207593 BACKGROUND

• 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.

  PMID: 23963867 BACKGROUND

• 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.

  PMID: 28574735 BACKGROUND

• 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.

  PMID: 29865201 BACKGROUND

• 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.

  PMID: 17178494 BACKGROUND

• 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.

  PMID: 24325331 BACKGROUND

• 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.

  PMID: 8361725 BACKGROUND

• 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.

  PMID: 27681402 BACKGROUND

• 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.

  PMID: 25243950 BACKGROUND

• 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.

  PMID: 25025462 BACKGROUND

• 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.

  PMID: 29566996 BACKGROUND

• 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.

  PMID: 27160933 BACKGROUND

• 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.

  PMID: 25963973 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

There are going to collect saliva for this study, which is going to be stored for 10 years as the maximum limit.

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Leukemia, Myeloid

Study Officials

• Reyna A Quispe, MsC

  Faculdade de Odontologia de Bauru, Universidade de São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of the Department of Surgery, Stomatology, Pathology and Radiology - Bauru School of Dentistry - University of São Paulo

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: July 20, 2021
• Study Start: September 1, 2019
• Primary Completion: July 8, 2021
• Study Completion: December 17, 2022
• Last Updated: March 8, 2024

Record last verified: 2024-03

Locations

BR (1)