Impact of the Use of Zinc in the Prevention of Oral Mucositis in Patients With Lymphoblastic Acute Leukemia of the National Institute of Pediatrics
Impact of the Use of Zinc in the Prevention of Oral Mucositis in Pediatric Patients With Lymphoblastic Acute Leukemia
Sponsors
Source
National Institute of Pediatrics, Mexico
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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 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
Enrolling by invitation
Start Date
2019-06-10
Completion Date
2020-08-30
Primary Completion Date
2020-06-30
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
106
Condition
Intervention
Intervention Type
Drug
Intervention Name
Description
The tablets were manufactured specifically for this study.
Arm Group Label
Group 2
Other Name
Zinc
Intervention Type
Drug
Intervention Name
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
Last Name |
Role |
Affiliation |
|
Marta M Zapata, Doctor |
Principal Investigator |
National Institute of Pediatrics |
Location
Facility |
|
Marta M. Zapta Tarrés Mexico 04530 Mexico |
Location Countries
Country
Mexico
Verification Date
2020-03-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
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
Intervention Browse
Mesh Term
Zinc
Zinc Sulfate
Arm Group
Arm Group Label
Group1
Arm Group Type
Placebo Comparator
Description
Control
Arm Group Label
Group 2
Arm Group Type
Experimental
Description
Intervention (Zinc)
Firstreceived Results Date
N/A
Reference
Citation
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. Review.
PMID
26622207
Citation
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.
PMID
29794779
Citation
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.
PMID
29551172
Citation
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.
PMID
23413048
Citation
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. Review.
PMID
29128883
Citation
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.
PMID
23720981
Citation
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.
PMID
22615642
Citation
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.
PMID
27418192
Citation
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. doi: 012157/AIM.008.
PMID
22724877
Citation
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.
PMID
21692101
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
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.
Study First Submitted
March 7, 2020
Study First Submitted Qc
March 23, 2020
Study First Posted
March 25, 2020
Last Update Submitted
March 23, 2020
Last Update Submitted Qc
March 23, 2020
Last Update Posted
March 25, 2020
Provided Document Section
Provided Document
Document Type
Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Document Has Protocol
Yes
Document Has Icf
Yes
Document Has Sap
Yes
Document Date
October 30, 2019
Document Url
https://ClinicalTrials.gov/ProvidedDocs/50/NCT04321850/Prot_SAP_ICF_000.pdf
ClinicalTrials.gov processed this data on March 27, 2020
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.