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

NCT04321850 | Terminated DMC

• 1 other identifier: 036/2019
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Mucositis

Keywords

Zinc; Leukemia, Acute Lymphoblastic

Outcome Measures

Primary Outcomes (3)

• Incidence of oral mucositis

  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

  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

  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 Outcomes (2)

• 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)

Study Arms (2)

Group1

PLACEBO COMPARATOR

Control

Drug: Placebo oral tablet

Group 2

EXPERIMENTAL

Intervention (Zinc)

Drug: Zinc Sulfate 50 Mg Tab

Interventions

Zinc Sulfate 50 Mg Tab DRUG

The tablets were manufactured specifically for this study.

Also known as: Zinc

Group 2

Placebo oral tablet DRUG

The tablets were manufactured specifically for this study.

Also known as: Manitol

Group1

Eligibility Criteria

• Age: 3 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients with another disease or systemic condition in addition to ALL.
• Patients with Down syndrome
• Patients allergic to zinc or mannitol.

Sponsors & Collaborators

• National Institute of Pediatrics, Mexico: lead
• Hospital Infantil de Mexico Federico Gomez: collaborator

Study Sites (1)

Marta M. Zapta Tarrés

México, 04530, Mexico

Location

Related Publications (10)

• 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.

  PMID: 26622207 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 29128883 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 22724877 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Stomatitis; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Zinc Sulfate; Zinc; Mannitol

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Inorganic Chemicals; Zinc Compounds; Metals, Heavy; Elements; Transition Elements; Metals; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Study Officials

• Marta M Zapata, Doctor

  National Institute of Pediatrics

  PRINCIPAL INVESTIGATOR

• Luis E Juárez, Doctor

  Federico Gomez Children's Hospital of Mexico

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician oncologist

Model Details: 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).

Study Record Dates

• First Submitted: March 7, 2020
• First Posted: March 25, 2020
• Study Start: June 10, 2019
• Primary Completion: June 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 4, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)