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

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

Sponsors

Lead Sponsor: National Institute of Pediatrics, Mexico

Collaborator: Hospital Infantil de Mexico Federico Gomez

Source National Institute of Pediatrics, Mexico
Brief 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.

Detailed Description

Objective: To evaluate the impact of the use of zinc in the prevention, incidence and severity of oral mucositis in patients with acute lymphoblastic leukemia in chemotherapy (induction and consolidation phase) of the National Institute of Pediatrics and the Federico Gómez Children's Hospital of Mexico during the period from 2019 to 2020. Methodology: Double-blind randomized clinical trial conducted in pediatric patients with newly diagnosed or relapsed acute lymphoblastic leukemia. The subjects will be randomized to designate them in the control group (Group1 placebo) or intervention group (Group 2 zinc). The zinc / placebo intervention will be administered orally in tablets of 50-100 mg / day, from day 1 of chemotherapy until the end of the consolidation phase (2 to 2.5 months). For the detection of OM the mucositis scale of the World Health Organization will be used and the observation times will correspond to day 1, 4, 7, 14 and 21 of each chemotherapy cycle. Patients of both groups with OM will receive the same treatment (mouthwash of Gelclair) and will be observed daily until healing to determine the days of recovery. Statistical analysis: Independent t-test and Chi-square test for the difference between the two study groups, ANOVA to compare the groups with respect to the severity of OM.

Overall Status Terminated
Start Date June 10, 2019
Completion Date July 30, 2020
Primary Completion Date June 30, 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Incidence of oral mucositis Participants will be followed for the duration of the induction and cosolidation phase of chemotherapy, an expected average of 2 to 2.5 months.
Oral mucositis grade Day 1 oral mucositis start to healing (1-14 days).
Pain intensity: Visual analog scale Day 1 oral mucositis start to healing (1-14 days).
Secondary Outcome
Measure Time Frame
Presence of opportunistic oral infections Day 1, 4, 7, 14 and 21 of the induction and consolidation phase.
Neutropenia During the induction and consolidation phase. Day 1, 4, 7, 14 and 21 of each phase. (2 to 2.5 months)
Enrollment 21
Condition
Intervention

Intervention Type: Drug

Intervention Name: Zinc Sulfate 50 Mg Tab

Description: The tablets were manufactured specifically for this study.

Arm Group Label: Group 2

Other Name: Zinc

Intervention Type: Drug

Intervention Name: Placebo oral tablet

Description: The tablets were manufactured specifically for this study.

Arm Group Label: Group1

Other Name: Manitol

Eligibility

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.

Gender: All

Minimum Age: 3 Years

Maximum Age: 18 Years

Healthy Volunteers: No

Overall Official
Location
Facility: Marta M. Zapta Tarrés
Location Countries

Mexico

Verification Date

July 2020

Responsible Party

Type: Principal Investigator

Investigator Affiliation: National Institute of Pediatrics, Mexico

Investigator Full Name: Marta Zapata Tarrés

Investigator Title: Pediatrician oncologist

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Group1

Type: Placebo Comparator

Description: Control

Label: Group 2

Type: Experimental

Description: Intervention (Zinc)

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Intervention Model Description: The subjects will be randomized to designate them in the control group (Group1 placebo) or intervention group (Group 2 zinc). The zinc / placebo intervention will be administered orally in tablets of 50-100 mg / day, from day 1 of chemotherapy until the end of the consolidation phase (2 to 2.5 months).

Primary Purpose: Prevention

Masking: Triple (Participant, Care Provider, Investigator)

Masking Description: The patient and the investigator will be blinded; for this, the 50 mg zinc and placebo tablets will be similar in size, color, shape, weight and taste; the bottles will be classified into codes A and B, which in turn will have the same shape, size and color. All of the above will be done through the Pharmaceuticals GREMAR S.A. de C.V., which is a Mexican company that has a line of food supplements located in Mexico City. An independent investigator (who will be blinded for the purpose of the study) will be requested to receive the medications (zinc / placebo) prepared by the Pharmaceuticals GREMAR S.A. of C.V., so that it provides to the principal investigator only the bottles coded as "A" and "B". At the end of the intervention, the independent investigator will be asked to reveal the coding of the medications to determine which group (Group 1 placebo or Group 2 zinc) corresponds to treatment A and B respectively.

Source: ClinicalTrials.gov