OmegaChild - Omega-3 Supplementation to Children Previously Treated for Cancer

NCT02134600 | Completed Phase 1

• 1 other identifier: 20130321
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find an optimal dose of omega-3 that can be given to children who have completed cancer therapy. The future aim is to add omega-3 to conventional cancer treatment modalities and thereby hopefully increase the treatment efficacy, which will have to be addressed in subsequent phase-2 studies.

Conditions

Pediatric Cancer

Keywords

Omega-3 fatty acids; DHA; EPA; Docosahexaenoic acid; Eicosapentaenoic acid; Childhood cancer; Body composition; Inflammation; Neuropsychiatric symptoms

Outcome Measures

Primary Outcomes (1)

• Omega-3 index

  Omega-3 index is defined as % of DHA + EPA of total fatty acids in erythrocyte membranes. (DHA: Docosahexaenoic acid. EPA: Eicosapentaenoic acid).

  3 months

Secondary Outcomes (1)

• Adverse Events

  3 months

Other Outcomes (1)

• Compliance

  3 months

Study Arms (1)

Omega-3 enriched fruit juice

EXPERIMENTAL

Single arm study: Omega-3 enriched fruit juice in increasing dosage

Dietary Supplement: Omega-3 enriched fruit juice

Interventions

Omega-3 enriched fruit juice DIETARY_SUPPLEMENT

Different doses of omega-3 will be administered to five different groups: 400, 800, 1200, 2400 and 3000 mg/m2.

Also known as: Nutrifriend by Smartfish AS

Omega-3 enriched fruit juice

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• years old
• Diagnosed with and now in complete clinical remission from any type of cancer
• Completed conventional therapy according to specific protocols within three years
• Spoken and written Swedish is understood by caregiver and/or child
• Expected to attend clinical follow-ups the coming three months.
• Performance Level: Karnofsky ≥ 60% for patients \> 16 years of age and Lansky ≥ 60 for patients ≤16 years of age. Note: Neurologic deficits in patients with tumors of the CNS (central nervous system) must have been relatively stable for a minimum of 1 month prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
• Written informed consent by all caregivers and if possible by the child after 7 years of age.

You may not qualify if:

• Known coagulation disorder
• Expected elective invasive surgery during the treatment
• Allergic to: fish or fish oil, protein from cow milk, fruit juice from any of the included fruits (apple, pear, pomegranate, passion fruit, peach, aronia)
• Supplementation of omega-3 during the last month
• Regular intake of NSAIDs (nonsteroidal antiinflammatory drugs), aspirin (ASA) or vitamin D
• Breastfeeding or pregnancy
• Participates in other clinical trials where results may be altered by additional intervention

Sponsors & Collaborators

• Per Kogner: lead
• Smartfish AS: collaborator

Study Sites (1)

Childhood Cancer Research Unit, Astrid Lindgren Children´s Hospital, Karolinska Institutet

Stockholm, 17176, Sweden

Location

Related Publications (4)

• Gleissman H, Segerstrom L, Hamberg M, Ponthan F, Lindskog M, Johnsen JI, Kogner P. Omega-3 fatty acid supplementation delays the progression of neuroblastoma in vivo. Int J Cancer. 2011 Apr 1;128(7):1703-11. doi: 10.1002/ijc.25473. Epub 2010 May 24.

  PMID: 20499314 BACKGROUND

• Gleissman H, Johnsen JI, Kogner P. Omega-3 fatty acids in cancer, the protectors of good and the killers of evil? Exp Cell Res. 2010 May 1;316(8):1365-73. doi: 10.1016/j.yexcr.2010.02.039. Epub 2010 Mar 6.

  PMID: 20211172 BACKGROUND

• Gleissman H, Yang R, Martinod K, Lindskog M, Serhan CN, Johnsen JI, Kogner P. Docosahexaenoic acid metabolome in neural tumors: identification of cytotoxic intermediates. FASEB J. 2010 Mar;24(3):906-15. doi: 10.1096/fj.09-137919. Epub 2009 Nov 4.

  PMID: 19890019 BACKGROUND

• Lindskog M, Gleissman H, Ponthan F, Castro J, Kogner P, Johnsen JI. Neuroblastoma cell death in response to docosahexaenoic acid: sensitization to chemotherapy and arsenic-induced oxidative stress. Int J Cancer. 2006 May 15;118(10):2584-93. doi: 10.1002/ijc.21555.

  PMID: 16353135 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Per Kogner, Professor

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 7, 2014
• First Posted: May 9, 2014
• Study Start: May 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: September 2, 2016
• Last Updated: August 28, 2018

Record last verified: 2018-08

Locations

SE (1)