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

• Status: Terminated
• Trial end date: 2020-07-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: National Institute of Pediatrics, Mexico
• Collaborator: Hospital Infantil de Mexico Federico Gomez
• Treatments: Zinc; Zinc Sulfate

Criteria

Inclusion Criteria:

• Patients aged 3 to 18 years

• Patients with recent diagnosis of ALL or relapse

• Pacientes who accept by informed consent to participate in the study.

Exclusion Criteria:

• Patients with another disease or systemic condition in addition to ALL.

• Patients with Down syndrome

• Patients allergic to zinc or mannitol.