Effect of Enteral Docosahexaenoic Acid Administration in Children With Acute Lymphoblastic Leukemia
Condition: Acute Lymphoblastic Leukemia; Malnutrition
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Malnutrition
Study type: Interventional
Phase: Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Docosahexaenoic acid (DHA); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Children will be received either fish oil capsules (DHA group) or placebo capsules (placebo group) which is visually indistinguishable from DHA capsules (softgel). Each child will be receiving 100 mg/kg/day or placebo capsules without docosahexaenoic acid, during the first three months of treatment.; Children will be received either fish oil capsules (DHA group) or placebo capsules (placebo group) which is visually indistinguishable from DHA capsules (softgel). Each child will be receiving 100 mg/kg/day or placebo capsules without docosahexaenoic acid, during the first three months of treatment.
Other intervention name(s): omega 3 fatty acids; n-3 LC-PUFAs; long chain polyunsaturated fatty acids
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Docosahexaenoic acid; Nutritional status; Acute lymphoblastic leukemia; Long chain polyunsaturated fatty acids; n-3 fatty acids; Remission-induction phase