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Impact of the Use of Zinc in the Prevention of Oral Mucositis in Pediatric Patients With Lymphoblastic Acute Leukemia.

NCT04321850 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-08-04

No results posted yet for this study

Summary

Oral mucositis (OM) is a secondary complication of chemo/radiotherapy, which causes pain, dysphagia and predisposition to infections, being a frequent reason for hospitalization that may have an impact on the prognosis of cancer patients. Various interventions for the prevention of OM have been studied, including the use of zinc, which is a micronutrient that participates in various cellular functions and in wound repair, while showing a reduction in the incidence and severity of MO, so the purpose of the present study is to evaluate the impact of the use of zinc in the prevention of oropharyngeal mucositis in pediatric patients with acute lymphoblastic leukemia in chemotherapy, comparing it with the use of placebo.

Hypothesis: The use of zinc reduces the incidence and severity of OM in pediatric patients with ALL in chemotherapy compared to the control group.

Conditions

  • Oral Mucositis

Interventions

DRUG

Zinc Sulfate 50 Mg Tab

The tablets were manufactured specifically for this study.

DRUG

Placebo oral tablet

The tablets were manufactured specifically for this study.

Sponsors & Collaborators

  • Hospital Infantil de Mexico Federico Gomez

    collaborator OTHER

  • National Institute of Pediatrics, Mexico

    lead OTHER_GOV

Principal Investigators

  • Marta M Zapata, Doctor · National Institute of Pediatrics

  • Luis E Juárez, Doctor · Federico Gomez Children's Hospital of Mexico

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-10
Primary Completion
2020-06-30
Completion
2020-07-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321850 on ClinicalTrials.gov