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

This study is enrolling participants by invitation only.
Sponsor:
Collaborators:
National Council of Science and Technology, Mexico
Instituto Mexicano del Seguro Social
Information provided by (Responsible Party):
María de Lourdes Barbosa Cortés, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier:
NCT01051154
First received: January 15, 2010
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Acute Lymphoblastic Leukemia
Malnutrition
Dietary Supplement: Docosahexaenoic acid (DHA)
Dietary Supplement: Placebo
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Coordinación de Investigación en Salud, Mexico:

Primary Outcome Measures:
  • Nutritional status will be determined by the register of anthropometrical measurements, body composition by DEXA, and biochemical markers. [ Time Frame: At the time of diagnosis and the first three months of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment toxicity measured by complications and haematological and biochemical outcomes,will be evaluated according to criteria established by the World Health Organization. [ Time Frame: The first three months of treatment ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: The first three months of treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 268
Study Start Date: September 2010
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Docosahexaenoic acid (DHA)
This group will be receive the DHA supplement
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.
Other Names:
  • omega 3 fatty acids
  • n-3 LC-PUFAs
  • long chain polyunsaturated fatty acids
Placebo Comparator: Placebo
This group will be receive placebo
Dietary Supplement: 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.

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

Ages Eligible for Study:   4 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01051154

Locations
Mexico
Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social
Mexico, Distrito Federal, Mexico, 06720
Sponsors and Collaborators
Coordinación de Investigación en Salud, Mexico
National Council of Science and Technology, Mexico
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: Maria de Lourdes Barbosa-Cortes, MSc Instituto Mexicano del Seguro Social
  More Information

No publications provided

Responsible Party: María de Lourdes Barbosa Cortés, Associated Researcher, Coordinación de Investigación en Salud, Mexico
ClinicalTrials.gov Identifier: NCT01051154     History of Changes
Other Study ID Numbers: 2009-785-107, 113742
Study First Received: January 15, 2010
Last Updated: August 5, 2014
Health Authority: Mexico: Ethics Committee
Mexico: National Council of Science and Technology

Keywords provided by Coordinación de Investigación en Salud, Mexico:
Docosahexaenoic acid
Nutritional status
Acute lymphoblastic leukemia
Long chain polyunsaturated fatty acids
n-3 fatty acids
Remission-induction phase

Additional relevant MeSH terms:
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Leukemia, Lymphoid
Leukemia
Malnutrition
Nutrition Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014