Acute Lymphoblastic Leukemia Clinical Trial
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.
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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