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Effect of Vitamin D Diffiency on Oral Mucosa in Patients Recieving Methotrexate Chemotherapy (VitDandMTX)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04096846
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
Information provided by (Responsible Party):
Magy Ibrahim Anis Rizkallah, Assiut University

Brief 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 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.

Condition or disease Intervention/treatment
Acute Lymphoblastic Leukemia Diagnostic Test: laboratory investigation

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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Estimated Study Start Date : November 1, 2019
Estimated Primary Completion Date : November 1, 2020
Estimated Study Completion Date : December 1, 2020

Intervention Details:
  • Diagnostic Test: laboratory investigation
    detection of serum level of methotrexate and serum level of vitamin D

Primary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
pediatric and old patients with acute lymphocytic leukemia treated with methotrexate based chemotherapy

Inclusion Criteria:

  • patients with acute lymphocytic leukemia in South Egypt Cancer Institute
  • patients recieving methotrexate in protocol of treatment
  • both sex included

Exclusion Criteria:

  • patients with other types of tumors
  • patients refuse to join the research
  • patients with comorbid hepatic or renal impairment

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04096846

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Contact: Magy Ibrahim Anis Rizkallah, Bachelor 01282495775

Sponsors and Collaborators
Assiut University
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Study Director: Moustafa Mahmoud Hamdy, Phd Assiut University
Study Director: Nevin Abdelazim Abelalim, Phd Assiut University
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Responsible Party: Magy Ibrahim Anis Rizkallah, Demonstrator of cancer biology, Assiut University Identifier: NCT04096846    
Other Study ID Numbers: Vit D and oral mucositis
First Posted: September 20, 2019    Key Record Dates
Last Update Posted: September 20, 2019
Last Verified: September 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases