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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


Phase 2
4 Years
15 Years
Open (Enrolling by invite only)
Both
Acute Lymphoblastic Leukemia, Malnutrition

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Nutritional status will be determined by the register of anthropometrical measurements, body composition by DEXA, and biochemical markers.

Outcome Time Frame:

At the time of diagnosis and the first three months of treatment

Safety Issue:

No

Principal Investigator

Maria de Lourdes Barbosa-Cortes, MSc

Investigator Role:

Principal Investigator

Investigator Affiliation:

Instituto Mexicano del Seguro Social

Authority:

Mexico: Ethics Committee

Study ID:

2009-785-107

NCT ID:

NCT01051154

Start Date:

September 2010

Completion Date:

December 2013

Related Keywords:

  • Acute Lymphoblastic Leukemia
  • Malnutrition
  • Docosahexaenoic acid
  • Nutritional status
  • Acute lymphoblastic leukemia
  • Long chain polyunsaturated fatty acids
  • n-3 fatty acids
  • Remission-induction phase
  • Leukemia
  • Leukemia, Lymphoid
  • Precursor Cell Lymphoblastic Leukemia-Lymphoma
  • Malnutrition

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