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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04321850
Recruitment Status : Enrolling by invitation
First Posted : March 25, 2020
Last Update Posted : April 27, 2020
Sponsor:
Collaborator:
Hospital Infantil de Mexico Federico Gomez
Information provided by (Responsible Party):
Marta Zapata Tarrés, 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.


Condition or disease Intervention/treatment Phase
Oral Mucositis Drug: Zinc Sulfate 50 Mg Tab Drug: Placebo oral tablet Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 106 participants
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).
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.

Primary Purpose: Prevention
Official Title: Impact of the Use of Zinc in the Prevention of Oral Mucositis in Pediatric Patients With Lymphoblastic Acute Leukemia.
Actual Study Start Date : June 10, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : August 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arm Intervention/treatment
Placebo Comparator: Group1
Control
Drug: Placebo oral tablet
The tablets were manufactured specifically for this study.
Other Name: Manitol

Experimental: Group 2
Intervention (Zinc)
Drug: Zinc Sulfate 50 Mg Tab
The tablets were manufactured specifically for this study.
Other Name: Zinc




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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



Secondary Outcome Measures :
  1. 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

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321850


Locations
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Mexico
Marta M. Zapta Tarrés
Mexico, Mexico, 04530
Sponsors and Collaborators
National Institute of Pediatrics, Mexico
Hospital Infantil de Mexico Federico Gomez
Investigators
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Principal Investigator: Marta M Zapata, Doctor National Institute of Pediatrics
Principal Investigator: Luis E Juárez, Doctor Federico Gomez Children's Hospital of Mexico
  Study Documents (Full-Text)

Documents provided by Marta Zapata Tarrés, National Institute of Pediatrics, Mexico:
Publications:

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Responsible Party: Marta Zapata Tarrés, Pediatrician oncologist, National Institute of Pediatrics, Mexico
ClinicalTrials.gov Identifier: NCT04321850    
Other Study ID Numbers: 036/2019
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: April 27, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Marta Zapata Tarrés, National Institute of Pediatrics, Mexico:
Zinc
Leukemia, Acute Lymphoblastic
Additional relevant MeSH terms:
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Leukemia
Mucositis
Stomatitis
Neoplasms by Histologic Type
Neoplasms
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases
Zinc
Zinc Sulfate
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Astringents
Dermatologic Agents