Oral Health Condition and Quality of Life in Children With Leukemia

March 6, 2024 updated by: Paulo Sergio da Silva Santos

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Daniela R Honório, PhD
  • Phone Number: 55143235-8223
  • Email: danirios@usp.br

Study Locations

  • Brazil
    • São Paulo
      • Bauru, São Paulo, Brazil, 17012-901
        • Faculdade de Odontologia de Bauru, Universidade de São Paulo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 17 years (Child)

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
  • 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.
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
5 minutes to 10 minutes
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)
10 minutes to 15 minutes
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).
10 minutes to 15 minutes
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).
5 minutes to 10 minutes
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.
1 minutes to 2 minutes
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.
15 minutes to 20 minutes
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.
10 to 15 minutes
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.
10 to 15 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Paulo Sergio da Silva Santos

Investigators

  • Principal Investigator: Reyna A Quispe, MsC, Faculdade de Odontologia de Bauru, Universidade de São Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2019

Primary Completion (Actual)

July 8, 2021

Study Completion (Actual)

December 17, 2022

Study Registration Dates

First Submitted

June 3, 2020

First Submitted That Met QC Criteria

July 8, 2021

First Posted (Actual)

July 20, 2021

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 6, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEUKEMIARAQ

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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