Oral Mucositis Clinical Trial
Official title:
Impact of the Use of Zinc in the Prevention of Oral Mucositis in Pediatric Patients With Lymphoblastic Acute Leukemia.
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02229136 -
Miracle Mouthwash Plus Hydrocortisone vs Prednisolone Mouth Rinse for Mouth Sores Caused by Everolimus
|
Phase 2 | |
| Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
| Enrolling by invitation |
NCT02662374 -
Oral Hygiene Regimen in Patients on HCT
|
Phase 4 | |
| Completed |
NCT00938080 -
Study to Assess Safety and Tolerability of AG013 in Oral Mucositis in Subjects Receiving Induction Chemotherapy for the Treatment of Cancers of the Head and Neck
|
Phase 1 | |
| Completed |
NCT00756951 -
Dose Ranging Study to Assess the Safety and Efficacy of SCV-07 for the Delay to Onset of Severe Oral Mucositis in Patients Receiving Chemoradiation Therapy for Head and Neck Cancer
|
Phase 2 | |
| Completed |
NCT00701688 -
Dose Escalation Study Of Palifermin in Pediatric Research Participants Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
|
Phase 1 | |
| Not yet recruiting |
NCT05059613 -
Thalidomide With or Without Probiotics in Radioactive Oral Mucositis
|
N/A | |
| Completed |
NCT04440930 -
White Tea for Prevention of Chemotherapy Induced Mucositis
|
N/A | |
| Completed |
NCT05705622 -
The Effect of Nursing Education on Oral Mucositis in Bone Marrow Transplant Patients
|
N/A | |
| Completed |
NCT02399228 -
A Trial of a Botanical Drug Containing East Indian Sandalwood Oil (EISO) for the Treatment of Oral Mucositis
|
Phase 2 | |
| Withdrawn |
NCT02589860 -
Analysis of Oral Mucositis in Patient's Undergoing Melphalan Conditioning and Autologous Stem Cell Transplant
|
||
| Active, not recruiting |
NCT01772706 -
Laser Mucite ORL : Effectiveness of Laser Therapy for Mucositis Induced by a Radio-chemotherapy in Head and Neck Cancer
|
N/A | |
| Enrolling by invitation |
NCT06122636 -
Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC
|
N/A | |
| Completed |
NCT03689712 -
ROMAN: Phase 3 Trial Investigating the Effects of GC4419 on Radiation Induced Oral Mucositis in Head/Neck Cancer Patients
|
Phase 3 | |
| Terminated |
NCT02539342 -
Caphosol Study: Prevention of Oral Mucositis in Children, Adolescents and Young Adults Receiving Chemotherapy
|
Phase 3 | |
| Completed |
NCT02555501 -
Oral Mucositis and Laser Therapy Associated With Photodynamic Therapy
|
Phase 3 | |
| Completed |
NCT01789658 -
Cryotherapy for Prevention of Oral Mucositis in Children Undergoing Hematopoietic Stem Cell Transplantation
|
N/A | |
| Completed |
NCT00790322 -
Efficacy and Safety Study of SBG vs Placebo in Head and Neck Cancer Patients Undergoing Radiation Therapy
|
Phase 3 | |
| Recruiting |
NCT00549952 -
Observational Study of Anti-Cancer Therapy Induced Oral Mucositis in Korean Cancer Patients
|
N/A | |
| Completed |
NCT00289003 -
The Protective Effect of Soluble Beta-1,3/1,6-Glucan Compared to Placebo in Oral Mucositis in Head and Neck Cancer Patients
|
Phase 2 |