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| ID | Type | Description | Link |
|---|---|---|---|
| 113742 | Other Grant/Funding Number | CONACyT |
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| Name | Class |
|---|---|
| National Council of Science and Technology, Mexico | OTHER |
| Instituto Mexicano del Seguro Social | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Docosahexaenoic acid (DHA) | Active Comparator | This group will be receive the DHA supplement |
|
| Placebo | Placebo Comparator | This group will be receive placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Docosahexaenoic acid (DHA) | Dietary Supplement | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Maria de Lourdes Barbosa-Cortes, MSc | Instituto Mexicano del Seguro Social | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social | Mexico City | Mexico City | 06720 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15159222 | Background | Larsson SC, Kumlin M, Ingelman-Sundberg M, Wolk A. Dietary long-chain n-3 fatty acids for the prevention of cancer: a review of potential mechanisms. Am J Clin Nutr. 2004 Jun;79(6):935-45. doi: 10.1093/ajcn/79.6.935. | |
| 37549598 | Derived | Barbosa-Cortes L, Martinez-Vieyra X, Mejia-Arangure JM, Lopez-Alarcon M, Martin-Trejo J, Delgadillo-Portillo S, Guzman-Castro B, Delgadillo-Portillo J, Atilano-Miguel S, Rodriguez-Cruz M, Maldonado-Hernandez J, Anoveros-Barrera A, Solis-Labastida KA, Espinoza-Hernandez L, Nunez-Villegas NN, Jimenez-Hernandez E, Bautista-Martinez BA, Juarez-Moya A, Hernandez-Pinon Z, Perez-Casillas RX. Pilot study on the effect of supplementation with long-chain omega-3 polyunsaturated fatty acids on body composition in children with acute lymphoblastic leukemia: randomized clinical trial. Clin Nutr. 2023 Sep;42(9):1759-1769. doi: 10.1016/j.clnu.2023.06.022. Epub 2023 Jul 13. |
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| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D004281 | Docosahexaenoic Acids |
| D015525 | Fatty Acids, Omega-3 |
| ID | Term |
|---|---|
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D008055 | Lipids |
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| Placebo | Dietary Supplement | 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. |
|
| The first three months of treatment |
| 37124732 | Derived | Barbosa-Cortes L, Atilano-Miguel S, Martin-Trejo JA, Jimenez-Aguayo E, Martinez-Becerril FI, Lopez-Alarcon M, Mejia Arangure JM, Maldonado-Hernandez J, Delgadillo-Portillo S, Guzman-Castro B, Delgadillo-Portillo J, Anoveros-Barrera A, Solis-Labastida KA, Bautista-Martinez BA, Juarez-Moya A, Hernandez-Pinon Z, Espinoza Hernandez LE, Nunez-Villegas NN, Jimenez-Hernandez E, Perez-Casillas RX. Effect of long-chain omega-3 polyunsaturated fatty acids on cardiometabolic factors in children with acute lymphoblastic leukemia undergoing treatment: a secondary analysis of a randomized controlled trial. Front Endocrinol (Lausanne). 2023 Apr 14;14:1120364. doi: 10.3389/fendo.2023.1120364. eCollection 2023. |
| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |