An observational study in Acute Lymphoblastic Leukemia, sponsored by Assiut University. Status unknown. Open to participants aged 5 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-09-20.
Sponsored by Assiut University · Observational
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.
5,441 studies on the registry are indexed under Leukemia; 636 are open to participants now.
This study's planned enrollment of 100 is below the median of 120 across 744 observational studies indexed under Leukemia.
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pediatric and old patients with acute lymphocytic leukemia treated with methotrexate based chemotherapy
Exclusion Criteria:
detection of serum level of methotrexate and serum level of vitamin D
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.
Time frame: baseline 6 months to 1 year
No study locations are listed for this record.
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Assiut University