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

Malnutrition Clinical Trial

— DHA-ALL  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01051154
• Other study ID #: 2009-785-107
• Secondary ID: 113742
• Status: Completed
• Phase: Phase 2
• First received: January 15, 2010
• Last updated: August 19, 2016
• Start date: September 2010
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ethics CommitteeMexico: National Council of Science and Technology
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 15 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Malnutrition
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

Dietary Supplement:
• Docosahexaenoic acid (DHA)
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.
• Placebo
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.

Locations

Country	Name	City	State
Mexico	Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social	Mexico	Distrito Federal

Sponsors (3)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico	Instituto Mexicano del Seguro Social, National Council of Science and Technology, Mexico

Country where clinical trial is conducted

Mexico, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No