Oral MucositisNCT04321850
Impact of the Use of Zinc in the Prevention of Oral Mucositis in Pediatric Patients With Lymphoblastic Acute Leukemia.
A study testing Zinc Sulfate 50 Mg Tab in people with Oral Mucositis, run by National Institute of Pediatrics, Mexico at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Oral Mucositis
- What is being tested?
- Zinc Sulfate 50 Mg Tab
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 21 participants
- Where
- 1 siteMexico
- Study dates
- 10 Jun 2019to 30 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patients with another disease or systemic condition in addition to ALL.
- Patients with Down syndrome
- Patients allergic to zinc or mannitol.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Oral Mucositis
- Being tested
- Zinc Sulfate 50 Mg Tab, Placebo oral tablet
- Keywords
- Zinc, Leukemia, Acute Lymphoblastic
- Medical subject headings
- Stomatitis, Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zinc Sulfate 50 Mg TabDrug
Also called Zinc
The tablets were manufactured specifically for this study.
Placebo oral tabletDrug
Also called Manitol
The tablets were manufactured specifically for this study.
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Placebo comparator | Control Receives: Drug: Placebo oral tablet |
| Group 2 | Experimental | Intervention (Zinc) Receives: Drug: Zinc Sulfate 50 Mg Tab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Measured: Day 1 oral mucositis start to healing (1-14 days).
Secondary outcomes (2)
Presence of opportunistic oral infections
Clinical or laboratory test. Record of suggestive lesions by C. albicans and determination by means of KOH, suggestive lesions of herpes and determination by PCR, suggestive bacterial lesions and detection through cultures.
- Absent
- Fungal
- Bacterial
- Viral
Measured: Day 1, 4, 7, 14 and 21 of the induction and consolidation phase.
Neutropenia
Absolute neutrophil count obtained by laboratory test (blood count).
- Absence of neutropenia
- Mild: 1,000-1,500 / ml
- Moderate: 500-1,000 / ml
- Severe: <500 / ml
Measured: During the induction and consolidation phase. Day 1, 4, 7, 14 and 21 of each phase. (2 to 2.5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2020
- Study start10 Jun 2019
- Primary completion30 Jun 2020
- Study completion30 Jul 2020
Why it stopped: Health restrictions due to the COVID-19 pandemic
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Oral MucositisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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).
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Pediatrics, Mexico
- Sponsor type
- Other government
- Collaborators
- Hospital Infantil de Mexico Federico Gomez
- Responsible party
- Principal investigator, Marta Zapata Tarrés, National Institute of Pediatrics, Mexico
- Investigators
- Marta M Zapata, Doctor, Principal investigator, National Institute of PediatricsLuis E Juárez, Doctor, Principal investigator, Federico Gomez Children's Hospital of Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04321850
- Sponsor's protocol ID
- 036/2019
- Status last verified
- Jul 2020
- First submitted
- 7 Mar 2020
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26622207Tian 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.
PubMed 29794779Rambod 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.
PubMed 29551172Miller 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.
PubMed 23413048He 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.
PubMed 29128883Sangthawan 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.
PubMed 23720981Mehdipour 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.
PubMed 22615642Hayashi 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.
PubMed 27418192Arbabi-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.
PubMed 22724877Mansouri 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.
PubMed 21692101
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Use of Zinc in the Prevention of Oral Mucositis in Pediatric Patients With Lymphoblastic Acute Leukemia.
- ClinicalTrials.gov ID
- NCT04321850
- Acronym / sponsor ID
- 036/2019
- Conditions
- Oral Mucositis
- Keywords
- Zinc, Leukemia, Acute Lymphoblastic
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Health restrictions due to the COVID-19 pandemic
- Enrolment
- 21 participants (actual)
- Lead sponsor
- National Institute of Pediatrics, MexicoOther government
- Collaborators
- Hospital Infantil de Mexico Federico Gomez
- Study start
- 10 Jun 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 30 Jul 2020 (actual)
- First posted
- 25 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Group1 | Placebo comparator | Drug: Placebo oral tabletControl |
| Group 2 | Experimental | Drug: Zinc Sulfate 50 Mg TabIntervention (Zinc) |
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with another disease or systemic condition in addition to ALL.
- Patients with Down syndrome
- Patients allergic to zinc or mannitol.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zinc Sulfate 50 Mg TabAlso: ZincThe tablets were manufactured specifically for this study. | Drug | Group 2 |
| Placebo oral tabletAlso: ManitolThe tablets were manufactured specifically for this study. | Drug | Group1 |
Primary outcome
Incidence of oral mucositis
Time frame: Participants will be followed for the duration of the induction and cosolidation phase of chemotherapy, an expected average of 2 to 2.5 months.
Presence /absence The presence of oral mucositis will be measured in all patients during the induction and consolidation phase of chemotherapy.
Oral mucositis grade
Time frame: Day 1 oral mucositis start to healing (1-14 days).
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.
Pain intensity: Visual analog scale
Time frame: Day 1 oral mucositis start to healing (1-14 days).
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
2 secondary outcomes
Presence of opportunistic oral infections
Time frame: Day 1, 4, 7, 14 and 21 of the induction and consolidation phase.
Neutropenia
Time frame: During the induction and consolidation phase. Day 1, 4, 7, 14 and 21 of each phase. (2 to 2.5 months)
Results and safety
The study was stopped early (reason given: Health restrictions due to the COVID-19 pandemic). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- Background: PubMed 26622207Lowal 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.
- Background: PubMed 29794779Tian 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.
- Background: PubMed 29551172Rambod 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.
- Background: PubMed 23413048Miller 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.
- Background: PubMed 29128883He 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.
- Background: PubMed 23720981Sangthawan 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.
- Background: PubMed 22615642Mehdipour 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.
- Background: PubMed 27418192Hayashi 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.
- Background: PubMed 22724877Arbabi-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.
- Background: PubMed 21692101Mansouri 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta M Zapata, Doctor principal investigator
National Institute of Pediatrics
Luis E Juárez, Doctor principal investigator
Federico Gomez Children's Hospital of Mexico
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Zinc Sulfate 50 Mg Tab in people with Oral Mucositis, run by National Institute of Pediatrics, Mexico at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Health restrictions due to the COVID-19 pandemic). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of oral mucositis (time frame: Participants will be followed for the duration of the induction and cosolidation phase of chemotherapy, an expected average of 2 to 2.5 months.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04321850, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.