Malnutrition Clinical Trial
Official title:
The Effect of Enteral Administration of Polyunsaturated Omega-3 Fatty Acids on Nutritional Status; the Treatment Toxicity and Early Mortality in Children With Acute Lymphoblastic Leukemia - a Controlled Study
The purpose of this study is to evaluate if enteral docosahexaenoic acid (DHA) administration during the first three months of treatment reduces the deterioration of nutritional status, treatment toxicity and early mortality in children with acute lymphoblastic leukemia.
Cancer is often associated with malnutrition.The most of children with cancer loss weight,
and 50-80% of patients with cancer experience morbidity and mortality as a result of
progressive wasting.
As a consequence of malnutrition, patients with cancer may have a poorer outcome, reduced
effectiveness of chemotherapy and increased risk of chemotherapy-induced toxicity compared
to those who are well nourished at diagnosis. On the other hand, in the recent years, there
has been increased focus on the role of long chain polyunsaturated fatty acids and their
effect on prevention and treatment of several diseases. The results of animal studies and
adults with cancer have demonstrated that the consumption of long chain polyunsaturated
fatty acids can slow the growth of cancer, increase the efficacy of chemotherapy and reduce
loss weight and the side effects of the chemotherapy.
Beneficial effects of enteral long chain polyunsaturated fatty acids has been reported in
adults with cancer. However, in children with cancer the scientific reports are scarce;
therefore, is necessary to evaluate if the long chain polyunsaturated fatty acids
administration in children with acute lymphoblastic leukemia has the same effects on
clinical and nutritional outcomes that have been previously showed by different studies in
adults with cancer.
;
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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