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 |
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| 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. |
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| 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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| 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 |
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| Secondary Outcome |
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| Enrollment | 21 | ||||||||
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| 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 |
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| 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 |
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| Location |
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| Location Countries |
Mexico |
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| Verification Date |
July 2020 |
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| Responsible Party |
Type: Principal Investigator Investigator Affiliation: National Institute of Pediatrics, Mexico Investigator Full Name: Marta Zapata Tarrés Investigator Title: Pediatrician oncologist |
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| 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) |
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| 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. |
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