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Acute Lymphoblastic LeukemiaPhase 2DHA-ALLNCT01051154

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

A Phase 2 study testing Docosahexaenoic acid (DHA) in people with Acute Lymphoblastic Leukemia and Malnutrition, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 4 to 15 years
Conditions the study is for
Acute Lymphoblastic Leukemia, Malnutrition
What is being tested?
Docosahexaenoic acid (DHA)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
72 participants
Where
1 siteMexico
Study dates
Sep 2010to Aug 2016
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 15 years
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • 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

Who cannot join

  • Patients had received radiotherapy or chemotherapy
  • Parents who decide to decline of the study

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Unit of Research in Nutrition, Pediatric Hospital, Instituto Mexicano del Seguro Social

    Mexico City, Mexico City, 06720

Other trials in Mexico

About this study

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

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.

Read the 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.

Being tested
Docosahexaenoic acid (DHA), Placebo
Keywords
Docosahexaenoic acid, Nutritional status, Acute lymphoblastic leukemia, Long chain polyunsaturated fatty acids, n-3 fatty acids, Remission-induction phase
Medical subject headings
Precursor Cell Lymphoblastic Leukemia-Lymphoma, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Docosahexaenoic acid (DHA)Dietary supplement

    Also called omega 3 fatty acids, n-3 LC-PUFAs, long chain polyunsaturated fatty acids

    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.

  • PlaceboDietary supplement

    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.

Study groups in NCT01051154
Study groupRoleWhat they receive
Docosahexaenoic acid (DHA)Active comparatorThis group will be receive the DHA supplement
Receives: Dietary Supplement: Docosahexaenoic acid (DHA)
PlaceboPlacebo comparatorThis group will be receive placebo
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (2)

  1. Treatment toxicity measured by complications and haematological and biochemical outcomes,will be evaluated according to criteria established by the World Health Organization.

    Measured: The first three months of treatment

  2. 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

    Measured: The first three months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jan 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionAug 2016
  4. Study completionAug 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01051154
Sponsor's protocol ID
2009-785-107
Other IDs
113742
Acronym
DHA-ALL
Status last verified
Aug 2016
First submitted
15 Jan 2010
Last updated
22 Aug 2016
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • 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. doi: 10.1093/ajcn/79.6.935.

    PubMed 15159222

  • Barbosa-Cortes L, Martinez-Vieyra X, Mejia-Arangure JM, Lopez-Alarcon M, Martin-Trejo J, Delgadillo-Portillo S, Guzman-Castro B, Delgadillo-Portillo J, Atilano-Miguel S, Rodriguez-Cruz M, Maldonado-Hernandez J, Anoveros-Barrera A, Solis-Labastida KA, Espinoza-Hernandez L, Nunez-Villegas NN, Jimenez-Hernandez E, Bautista-Martinez BA, Juarez-Moya A, Hernandez-Pinon Z, Perez-Casillas RX. Pilot study on the effect of supplementation with long-chain omega-3 polyunsaturated fatty acids on body composition in children with acute lymphoblastic leukemia: randomized clinical trial. Clin Nutr. 2023 Sep;42(9):1759-1769. doi: 10.1016/j.clnu.2023.06.022. Epub 2023 Jul 13.

    PubMed 37549598

  • Barbosa-Cortes L, Atilano-Miguel S, Martin-Trejo JA, Jimenez-Aguayo E, Martinez-Becerril FI, Lopez-Alarcon M, Mejia Arangure JM, Maldonado-Hernandez J, Delgadillo-Portillo S, Guzman-Castro B, Delgadillo-Portillo J, Anoveros-Barrera A, Solis-Labastida KA, Bautista-Martinez BA, Juarez-Moya A, Hernandez-Pinon Z, Espinoza Hernandez LE, Nunez-Villegas NN, Jimenez-Hernandez E, Perez-Casillas RX. Effect of long-chain omega-3 polyunsaturated fatty acids on cardiometabolic factors in children with acute lymphoblastic leukemia undergoing treatment: a secondary analysis of a randomized controlled trial. Front Endocrinol (Lausanne). 2023 Apr 14;14:1120364. doi: 10.3389/fendo.2023.1120364. eCollection 2023.

    PubMed 37124732

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Docosahexaenoic acid (DHA) in people with Acute Lymphoblastic Leukemia and Malnutrition, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01051154, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2016.

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