Effect of Enteral Docosahexaenoic Acid Administration in Children With Acute Lymphoblastic Leukemia (DHA-ALL)

Coordinación de Investigación en Salud, Mexico

Status and phase: Completed; Phase 2

Conditions: Malnutrition; Acute Lymphoblastic Leukemia

Treatments: Dietary Supplement: Docosahexaenoic acid (DHA); Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01051154

2009-785-107

113742 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 4 to 15 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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72 participants in 2 patient groups, including a placebo group

Docosahexaenoic acid (DHA)

Active Comparator group

Description:

This group will be receive the DHA supplement

Treatment:

Dietary Supplement: Docosahexaenoic acid (DHA)

Placebo

Placebo Comparator group

Description:

This group will be receive placebo

Treatment:

Dietary Supplement: Placebo