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

Phase 2

Completed

• Conditions: Malnutrition; Acute Lymphoblastic Leukemia
• Interventions: Dietary Supplement: Docosahexaenoic acid (DHA); Dietary Supplement: Placebo

• Registration Number: NCT01051154
• Lead Sponsor: Coordinación de Investigación en Salud, Mexico

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.

Study Timeline

• Study First Submitted: 2010-01-15
• Study First Submitted QC: 2010-01-15
• Study First Posted: 2010-01-18
• Study Start: 2010-09
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-19
• Last Update Posted: 2016-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Docosahexaenoic acid (DHA)	Docosahexaenoic acid (DHA)	This group will be receive the DHA supplement
Placebo	Placebo	This group will be receive placebo

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social; 🇲🇽 Mexico, Distrito Federal, Mexico