Effect of Vitamin D Diffiency on Oral Mucosa in Patients Recieving Methotrexate Chemotherapy (VitDandMTX)
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|ClinicalTrials.gov Identifier: NCT04096846|
Recruitment Status : Not yet recruiting
First Posted : September 20, 2019
Last Update Posted : September 20, 2019
|Condition or disease||Intervention/treatment|
|Acute Lymphoblastic Leukemia||Diagnostic Test: laboratory investigation|
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 Type :||Observational|
|Estimated Enrollment :||100 participants|
|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|
- Diagnostic Test: laboratory investigation
detection of serum level of methotrexate and serum level of vitamin D
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04096846
|Contact: Magy Ibrahim Anis Rizkallah, Bachelorfirstname.lastname@example.org|
|Study Director:||Moustafa Mahmoud Hamdy, Phd||Assiut University|
|Study Director:||Nevin Abdelazim Abelalim, Phd||Assiut University|