NCT04968860

Oral Health Condition and Quality of Life in Children With Leukemia

Terminated Last updated 8 March 2024

What this trial tests

trial testing This study is observational in Leukemia, Lymphoblastic in 9 participants. Terminated before completion.

Timeline

1 September 2019

Primary endpoint
8 July 2021

17 December 2022

Quick facts

Lead sponsor	Paulo Sergio da Silva Santos
Status	Terminated
Study type	OBSERVATIONAL
Enrollment	9
Start date	1 September 2019
Primary completion	8 July 2021
Estimated completion	17 December 2022
Sites	1 location across Brazil

Drugs / interventions tested

• This study is observational

Conditions studied

• Leukemia, Lymphoblastic — all drugs for Leukemia, Lymphoblastic →
• Leukemia, Myeloid, Acute — all drugs for Leukemia, Myeloid, Acute →

Sponsor

Paulo Sergio da Silva Santos

Who can join

Adults 3 to 17, any sex, with Leukemia, Lymphoblastic or Leukemia, Myeloid, Acute. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.