Impact of the Use of Zinc in the Prevention of Oral Mucositis in Pediatric Patients With Lymphoblastic Acute Leukemia.
NCT ID: NCT04321850
Last Updated: 2020-08-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
21 participants
INTERVENTIONAL
2019-06-10
2020-07-30
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
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.
Study Groups
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Group1
Control
Placebo oral tablet
The tablets were manufactured specifically for this study.
Group 2
Intervention (Zinc)
Zinc Sulfate 50 Mg Tab
The tablets were manufactured specifically for this study.
Interventions
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Zinc Sulfate 50 Mg Tab
The tablets were manufactured specifically for this study.
Placebo oral tablet
The tablets were manufactured specifically for this study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with recent diagnosis of ALL or relapse
* Pacientes who accept by informed consent to participate in the study.
Exclusion Criteria
* Patients with Down syndrome
* Patients allergic to zinc or mannitol.
3 Years
18 Years
ALL
No
Sponsors
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Hospital Infantil de Mexico Federico Gomez
OTHER
National Institute of Pediatrics, Mexico
OTHER_GOV
Responsible Party
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Marta Zapata Tarrés
Pediatrician oncologist
Principal Investigators
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Marta M Zapata, Doctor
Role: PRINCIPAL_INVESTIGATOR
National Institute of Pediatrics
Luis E Juárez, Doctor
Role: PRINCIPAL_INVESTIGATOR
Federico Gomez Children's Hospital of Mexico
Locations
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Marta M. Zapta Tarrés
México, , Mexico
Countries
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References
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Lowal KA, Alaizari NA, Tarakji B, Petro W, Hussain KA, Altamimi MA. DENTAL CONSIDERATIONS FOR LEUKEMIC PEDIATRIC PATIENTS: AN UPDATED REVIEW FOR GENERAL DENTAL PRACTITIONER. Mater Sociomed. 2015 Oct;27(5):359-62. doi: 10.5455/msm.2015.27.359-362. Epub 2015 Oct 5.
Tian X, Chen WQ, Liu XL, Pi YP, Chen H. Efficacy and safety of oral zinc sulfate in the prevention of chemotherapy-induced oral mucositis: Protocol for a meta-analysis of randomized controlled trials. Medicine (Baltimore). 2018 May;97(21):e10839. doi: 10.1097/MD.0000000000010839.
Rambod M, Pasyar N, Ramzi M. The effect of zinc sulfate on prevention, incidence, and severity of mucositis in leukemia patients undergoing chemotherapy. Eur J Oncol Nurs. 2018 Apr;33:14-21. doi: 10.1016/j.ejon.2018.01.007. Epub 2018 Feb 2.
Miller MM, Donald DV, Hagemann TM. Prevention and treatment of oral mucositis in children with cancer. J Pediatr Pharmacol Ther. 2012 Oct;17(4):340-50. doi: 10.5863/1551-6776-17.4.340.
He M, Zhang B, Shen N, Wu N, Sun J. A systematic review and meta-analysis of the effect of low-level laser therapy (LLLT) on chemotherapy-induced oral mucositis in pediatric and young patients. Eur J Pediatr. 2018 Jan;177(1):7-17. doi: 10.1007/s00431-017-3043-4. Epub 2017 Nov 11.
Sangthawan D, Phungrassami T, Sinkitjarurnchai W. A randomized double-blind, placebo-controlled trial of zinc sulfate supplementation for alleviation of radiation-induced oral mucositis and pharyngitis in head and neck cancer patients. J Med Assoc Thai. 2013 Jan;96(1):69-76.
Mehdipour M, Taghavi Zenoz A, Asvadi Kermani I, Hosseinpour A. A comparison between zinc sulfate and chlorhexidine gluconate mouthwashes in the prevention of chemotherapy-induced oral mucositis. Daru. 2011;19(1):71-3.
Hayashi H, Kobayashi R, Suzuki A, Yamada Y, Ishida M, Shakui T, Kitagawa J, Hayashi H, Sugiyama T, Takeuchi H, Tsurumi H, Itoh Y. Preparation and clinical evaluation of a novel lozenge containing polaprezinc, a zinc-L-carnosine, for prevention of oral mucositis in patients with hematological cancer who received high-dose chemotherapy. Med Oncol. 2016 Aug;33(8):91. doi: 10.1007/s12032-016-0795-z. Epub 2016 Jul 14.
Arbabi-kalati F, Arbabi-kalati F, Deghatipour M, Ansari Moghadam A. Evaluation of the efficacy of zinc sulfate in the prevention of chemotherapy-induced mucositis: a double-blind randomized clinical trial. Arch Iran Med. 2012 Jul;15(7):413-7.
Mansouri A, Hadjibabaie M, Iravani M, Shamshiri AR, Hayatshahi A, Javadi MR, Khoee SH, Alimoghaddam K, Ghavamzadeh A. The effect of zinc sulfate in the prevention of high-dose chemotherapy-induced mucositis: a double-blind, randomized, placebo-controlled study. Hematol Oncol. 2012 Mar;30(1):22-6. doi: 10.1002/hon.999. Epub 2011 Jun 21.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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036/2019
Identifier Type: -
Identifier Source: org_study_id
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