Acute Lymphoblastic LeukemiaVitDandMTXNCT04096846
Effect of Vitamin D Diffiency on Oral Mucosa in Patients Recieving Methotrexate Chemotherapy
An observational study of Acute Lymphoblastic Leukemia, run by Assiut University.
Trial summary
it's a prospective study aiming to improve quality of life of patients with acute lymphoblastic leukemia suffering from oral mucositis, receiving courses of methotrexate chemotherapy , by measuring vitamin D in those patients before induction therapy and the change in its level during treatment, that associated with… Read more about this study
- Who is it for?
- Ages 5 to 60 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia
- What is being tested?
- laboratory investigation
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2019to 1 Dec 2020
- Phase
- Observational
- 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 5 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: pediatric and old patients with acute lymphocytic leukemia treated with methotrexate based chemotherapy
Who may be able to join
- patients with acute lymphocytic leukemia in South Egypt Cancer Institute
- patients recieving methotrexate in protocol of treatment
- both sex included
Who cannot join
- patients with other types of tumors
- patients refuse to join the research
- patients with comorbid hepatic or renal impairment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Relationship Between Vitamin D Deficiency and Oral Mucositis in Patients With Acute Lymphoblastic Leukemia Receiving Methotrexate in South Egypt Cancer Institute , a Prospective Study
it's a prospective study aiming to improve quality of life of patients with acute lymphoblastic leukemia suffering from oral mucositis, receiving courses of methotrexate chemotherapy , by measuring vitamin D in those patients before induction therapy and the change in its level during treatment, that associated with methotrexate-induced oral mucositis, taking in consideration serum level of methotrexate, so we may have assiotiation between vitamin D difficiency and oral mucositis . at the end we can have preventive interventions to protect against this harmful side effect.
Read the detailed description
Treatment outcome of acute lymphoblastic leukemia (ALL) is improved recently and the 5-year survival rates reached 90% in developed countries . So more research currently focuses on strategies to decrease toxic adverse effects of methotrexate (MTX). Oral mucositis occurs in about 20% of patients receiving methotrexate Identifying risk factors leading to this side effects would be valuable to develop preventive interventions and improve quality of life for these patients .
Previous studies revealed a relationship between vitamin D deficiency and chemotherapy-induced oral mucositis in cancer patients. This hormone is important in many physiological processes in the body as bone mineralization and immune regulations. The main sourses of Vitamin D is production in the skin through sunlight exposure, diet and Vitamin D supplements .
Previous literature showed that receptors for vitamin D expressed in the mucosa and so there is a relationship between vitamin D deficiency and increase inflammation and impairment of mucosa .
Patients with acute lymphoblastic leukemia maybe at risk of vitamin D deficiency because of impaired vitamin intake and sunlight exposure . In this study we examin the possible role of vitamin D in relation to methotrexate induced oral mucositis in cancer patients.
- peripheral blood samples from patients before starting chemotherapy course with methotrexate and 24 hr after starting the treatment for measurement level of vitamin D, samples centrifuged at the speed of 2000 - 3000 rpm for 20 min , then analyzed using ELISA.
- blood samples after treatment also used to determine serum level of methotrexate which may lead to toxic adverse effect as oral mucositis , samples centrifuged at speed of 2000 - 3000 rpm for 10 min and analyzed using Viva-E equipment.
- All serum samples were stored at -80 °C and analyzed collectively
- Conditions
- Acute Lymphoblastic Leukemia
- Being tested
- laboratory investigation
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory investigationDiagnostic test
detection of serum level of methotrexate and serum level of vitamin D
What is being measured
The primary outcome is the main question the study is designed to answer.
Relation between vitamin D difficiency and oral mucositis in patients with leukemia
Difficiency of vitamin D in patients with acute lymphoblastic leukemia recieving methotrexte assiociated with oral mucositis and so later on we can improve thier quality of life by supplying vitamin D.
Measured: baseline 6 months to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2019
- Study start1 Nov 2019 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magy Ibrahim Anis Rizkallah, Assiut University
- Investigators
- Moustafa Mahmoud Hamdy, Phd, Study director, Assiut UniversityNevin Abdelazim Abelalim, Phd, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04096846
- Sponsor's protocol ID
- Vit D and oral mucositis
- Acronym
- VitDandMTX
- Status last verified
- Sep 2019
- First submitted
- 18 Sep 2019
- Last updated
- 20 Sep 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Al-Maweri SA, Halboub E, Al-Sufyani G, Alqutaibi AY, Shamala A, Alsalhani A. Is vitamin D deficiency a risk factor for recurrent aphthous stomatitis? A systematic review and meta-analysis. Oral Dis. 2020 Sep;26(6):1116-1123. doi: 10.1111/odi.13189. Epub 2019 Oct 8.
PubMed 31493304Anand A, Singh S, Sonkar AA, Husain N, Singh KR, Singh S, Kushwaha JK. Expression of vitamin D receptor and vitamin D status in patients with oral neoplasms and effect of vitamin D supplementation on quality of life in advanced cancer treatment. Contemp Oncol (Pozn). 2017;21(2):145-151. doi: 10.5114/wo.2017.68623. Epub 2017 Jun 30.
PubMed 28947884Oosterom N, Dirks NF, Heil SG, de Jonge R, Tissing WJE, Pieters R, van den Heuvel-Eibrink MM, Heijboer AC, Pluijm SMF. A decrease in vitamin D levels is associated with methotrexate-induced oral mucositis in children with acute lymphoblastic leukemia. Support Care Cancer. 2019 Jan;27(1):183-190. doi: 10.1007/s00520-018-4312-0. Epub 2018 Jun 19.
PubMed 29922939Lalla RV, Choquette LE, Feinn RS, Zawistowski H, Latortue MC, Kelly ET, Baccaglini L. Multivitamin therapy for recurrent aphthous stomatitis: a randomized, double-masked, placebo-controlled trial. J Am Dent Assoc. 2012 Apr;143(4):370-6. doi: 10.14219/jada.archive.2012.0179.
PubMed 22467697
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Vitamin D Deficiency and Oral Mucositis in Patients With Acute Lymphoblastic Leukemia Receiving Methotrexate in South Egypt Cancer Institute , a Prospective Study
- ClinicalTrials.gov ID
- NCT04096846
- Acronym / sponsor ID
- VitDandMTX / Vit D and oral mucositis
- Conditions
- Acute Lymphoblastic Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2019 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 20 Sep 2019 (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.
it's a prospective study aiming to improve quality of life of patients with acute lymphoblastic leukemia suffering from oral mucositis, receiving courses of methotrexate chemotherapy , by measuring vitamin D in those patients before induction therapy and the change in its level during treatment, that associated with methotrexate-induced oral mucositis, taking in consideration serum level of methotrexate, so we may have assiotiation between vitamin D difficiency and oral mucositis . at the end we can have preventive interventions to protect against this harmful side effect.
Detailed description
Treatment outcome of acute lymphoblastic leukemia (ALL) is improved recently and the 5-year survival rates reached 90% in developed countries . So more research currently focuses on strategies to decrease toxic adverse effects of methotrexate (MTX). Oral mucositis occurs in about 20% of patients receiving methotrexate Identifying risk factors leading to this side effects would be valuable to develop preventive interventions and improve quality of life for these patients .
Previous studies revealed a relationship between vitamin D deficiency and chemotherapy-induced oral mucositis in cancer patients. This hormone is important in many physiological processes in the body as bone mineralization and immune regulations. The main sourses of Vitamin D is production in the skin through sunlight exposure, diet and Vitamin D supplements .
Previous literature showed that receptors for vitamin D expressed in the mucosa and so there is a relationship between vitamin D deficiency and increase inflammation and impairment of mucosa .
Patients with acute lymphoblastic leukemia maybe at risk of vitamin D deficiency because of impaired vitamin intake and sunlight exposure . In this study we examin the possible role of vitamin D in relation to methotrexate induced oral mucositis in cancer patients.
- peripheral blood samples from patients before starting chemotherapy course with methotrexate and 24 hr after starting the treatment for measurement level of vitamin D, samples centrifuged at the speed of 2000 - 3000 rpm for 20 min , then analyzed using ELISA.
- blood samples after treatment also used to determine serum level of methotrexate which may lead to toxic adverse effect as oral mucositis , samples centrifuged at speed of 2000 - 3000 rpm for 10 min and analyzed using Viva-E equipment.
- All serum samples were stored at -80 °C and analyzed collectively
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- pediatric and old patients with acute lymphocytic leukemia treated with methotrexate based chemotherapy
Key inclusion criteria (3 listed)
- patients with acute lymphocytic leukemia in South Egypt Cancer Institute
- patients recieving methotrexate in protocol of treatment
- both sex included
Key exclusion criteria (3 listed)
- patients with other types of tumors
- patients refuse to join the research
- patients with comorbid hepatic or renal impairment
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 |
|---|---|---|
| laboratory investigationdetection of serum level of methotrexate and serum level of vitamin D | Diagnostic test | – |
Primary outcome
Relation between vitamin D difficiency and oral mucositis in patients with leukemia
Time frame: baseline 6 months to 1 year
Difficiency of vitamin D in patients with acute lymphoblastic leukemia recieving methotrexte assiociated with oral mucositis and so later on we can improve thier quality of life by supplying vitamin D.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Sep 2019.
- Background: PubMed 31493304Al-Maweri SA, Halboub E, Al-Sufyani G, Alqutaibi AY, Shamala A, Alsalhani A. Is vitamin D deficiency a risk factor for recurrent aphthous stomatitis? A systematic review and meta-analysis. Oral Dis. 2020 Sep;26(6):1116-1123. doi: 10.1111/odi.13189. Epub 2019 Oct 8.
- Background: PubMed 28947884Anand A, Singh S, Sonkar AA, Husain N, Singh KR, Singh S, Kushwaha JK. Expression of vitamin D receptor and vitamin D status in patients with oral neoplasms and effect of vitamin D supplementation on quality of life in advanced cancer treatment. Contemp Oncol (Pozn). 2017;21(2):145-151. doi: 10.5114/wo.2017.68623. Epub 2017 Jun 30.
- Background: PubMed 29922939Oosterom N, Dirks NF, Heil SG, de Jonge R, Tissing WJE, Pieters R, van den Heuvel-Eibrink MM, Heijboer AC, Pluijm SMF. A decrease in vitamin D levels is associated with methotrexate-induced oral mucositis in children with acute lymphoblastic leukemia. Support Care Cancer. 2019 Jan;27(1):183-190. doi: 10.1007/s00520-018-4312-0. Epub 2018 Jun 19.
- Background: PubMed 22467697Lalla RV, Choquette LE, Feinn RS, Zawistowski H, Latortue MC, Kelly ET, Baccaglini L. Multivitamin therapy for recurrent aphthous stomatitis: a randomized, double-masked, placebo-controlled trial. J Am Dent Assoc. 2012 Apr;143(4):370-6. doi: 10.14219/jada.archive.2012.0179.
Related trials for Acute Lymphoblastic Leukemia
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
Not yet recruitingPhase 2
Obesity Treatment With Phentermine-Topiramate ER in AYA Surviving Leukemia and Lymphoma
Acute Lymphoblastic Leukemia in Remission, Hodgkin Lymphoma in Remission
Recruiting
A Multicenter Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-Cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymph...
B-All, Acute Lymphoblastic Leukemia
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Moustafa Mahmoud Hamdy, Phd study director
Assiut University
Nevin Abdelazim Abelalim, Phd study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 20 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magy Ibrahim Anis Rizkallah, Bachelor (01282495775, magyibraheem@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relation between vitamin D difficiency and oral mucositis in patients with leukemia (time frame: baseline 6 months to 1 year). 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 NCT04096846, which also lists 4 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 20 Sep 2019.