Clinical trial NCT01051154: Effect of Enteral Docosahexaenoic Acid Administration in Children With Acute Lymphoblastic Leukemia
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute Lymphoblastic Leukemia
Malnutrition
Keywords: Docosahexaenoic acid
Nutritional status
Acute lymphoblastic leukemia
Long chain polyunsaturated fatty acids
n-3 fatty acids
Remission-induction phase
Lead sponsor: Coordinación de Investigación en Salud, Mexico
Sponsor class: OTHER_GOV
Collaborators: name: National Council of Science and Technology, Mexico
name: Instituto Mexicano del Seguro Social
First posted: 2010-01-18
Enrollment: 72
Sex: ALL
Minimum age (years): 4
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Nutritional status will be determined by the register of anthropometrical measurements, body composition by DEXA, and biochemical markers.
timeFrame: At the time of diagnosis and the first three months of treatment
Secondary outcomes:
measure: Treatment toxicity measured by complications and haematological and biochemical outcomes,will be evaluated according to criteria established by the World Health Organization.
timeFrame: The first three months of treatment
measure: 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
timeFrame: The first three months of treatment
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social
state: Distrito Federal
Study officials:
affiliation: Instituto Mexicano del Seguro Social
name: Maria de Lourdes Barbosa-Cortes, MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.