Effect of Enteral Docosahexaenoic Acid Administration in Children With Acute Lymphoblastic Leukemia

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Acute Lymphoblastic Leukemia, Malnutrition

Intervention / Treatment
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* Dietary Supplement: Docosahexaenoic acid (DHA)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children with acute lymphoblastic leukemia diagnosis Authorization from both parents or legal guardian for recruiting of the child into the study with consent signed form after the purpose and procedures have been explained Must be able to swallow capsules of DHA or placebo Malnutrition Exclusion Criteria: Patients had received radiotherapy or chemotherapy Parents who decide to decline of the study

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Docosahexaenoic acid (DHA)<br>This group will be receive the DHA supplement | Dietary Supplement: Docosahexaenoic acid (DHA)<br>* 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.<br>* Other names: long chain polyunsaturated fatty acids;|
| Placebo Comparator: Placebo<br>This group will be receive placebo | Dietary Supplement: Placebo<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nutritional status will be determined by the register of anthropometrical measurements, body composition by DEXA, and biochemical markers. |  | At the time of diagnosis and the first three months of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment toxicity measured by complications and haematological and biochemical outcomes,will be evaluated according to criteria established by the World Health Organization. |  | The first three months of treatment | 
| Early mortality will be considered as the difference between the total number of individuals alive at the end of follow-up (3 months) unless the initial number of patients included in the study for each group |  | The first three months of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Docosahexaenoic acid, Nutritional status, Acute lymphoblastic leukemia, Long chain polyunsaturated fatty acids, n-3 fatty acids, Remission-induction phase