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

July 31, 2020 updated by: Marta Zapata Tarrés, National Institute of Pediatrics, Mexico

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

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

Study Locations

  • Mexico
      • Mexico, Mexico, 04530
        • Marta M. Zapta Tarrés

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 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Group1
Control
Drug: Placebo oral tablet
The tablets were manufactured specifically for this study.
Other Names:
  • Manitol
EXPERIMENTAL: Group 2
Intervention (Zinc)
Drug: Zinc Sulfate 50 Mg Tab
The tablets were manufactured specifically for this study.
Other Names:
  • Zinc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of oral mucositis
Time Frame: Participants will be followed for the duration of the induction and cosolidation phase of chemotherapy, an expected average of 2 to 2.5 months.
Presence /absence The presence of oral mucositis will be measured in all patients during the induction and consolidation phase of chemotherapy.
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
Time Frame: Day 1 oral mucositis start to healing (1-14 days).
World Health Organization (WHO) Criteria of Oral Mucositis The total score of this scale ranges from 0 to 4. Grade 0: no changes in the oral cavity are detected. Grade I: pain and erythema in mucosa, gums, tongue or palate. Grade II: erythema and ulcers, still with a solid diet tolerance. grade III: oral ulcers, tolerance to pasty foods and liquid diets. Grade IV: ulcers, erythema, pain, inability to swallow fluids, impossible oral feeding, and narcotic requirement to relieve pain.
Day 1 oral mucositis start to healing (1-14 days).
Pain intensity: Visual analog scale
Time Frame: Day 1 oral mucositis start to healing (1-14 days).

Visual analog scale Analogous visual scale of facial expressions, which is used in children 3 years and older. It is made up of faces with different expressions that represent a person who is happy because they do not feel pain or who is sad because they feel some pain or a lot of pain. A score is assigned to each face. The patient is asked to select the face that best describes how he feels.

It will be recorded by the numerical score and will then be coded as follows:

0-2 No pain 3-4 Mild 5-6 Moderate 7-8 Intense 9-10 Maximum
Day 1 oral mucositis start to healing (1-14 days).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence of opportunistic oral infections
Time Frame: Day 1, 4, 7, 14 and 21 of the induction and consolidation phase.

Clinical or laboratory test. Record of suggestive lesions by C. albicans and determination by means of KOH, suggestive lesions of herpes and determination by PCR, suggestive bacterial lesions and detection through cultures.

0. Absent

  1. Fungal
  2. Bacterial
  3. Viral
Day 1, 4, 7, 14 and 21 of the induction and consolidation phase.
Neutropenia
Time Frame: During the induction and consolidation phase. Day 1, 4, 7, 14 and 21 of each phase. (2 to 2.5 months)

Absolute neutrophil count obtained by laboratory test (blood count).

0. Absence of neutropenia

  1. Mild: 1,000-1,500 / ml
  2. Moderate: 500-1,000 / ml
  3. Severe: <500 / ml
During the induction and consolidation phase. Day 1, 4, 7, 14 and 21 of each phase. (2 to 2.5 months)

Collaborators and Investigators

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

Sponsor

National Institute of Pediatrics, Mexico

Collaborators

Hospital Infantil de Mexico Federico Gomez

Investigators

  • Principal Investigator: Marta M Zapata, Doctor, National Institute of Pediatrics
  • Principal Investigator: Luis E Juárez, Doctor, Federico Gomez Children's Hospital of Mexico

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)

June 10, 2019

Primary Completion (ACTUAL)

June 30, 2020

Study Completion (ACTUAL)

July 30, 2020

Study Registration Dates

First Submitted

March 7, 2020

First Submitted That Met QC Criteria

March 23, 2020

First Posted (ACTUAL)

March 25, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 4, 2020

Last Update Submitted That Met QC Criteria

July 31, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 036/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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