Clinical trial · Interventional
OmegaChild - Omega-3 Supplementation to Children Previously Treated for Cancer
OmegaChild - Omega-3 Supplementation to Children Now in Full Remission From a Previous Cancer; an Early Phase Dose-finding Study.
NCT02134600CI-TRIAL-00034615OmegaChildcompletedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Omega-3 enriched fruit juice | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Omega-3 enriched fruit juice
- description
- Single arm study: Omega-3 enriched fruit juice in increasing dosage
- interventionNames
- Dietary Supplement: Omega-3 enriched fruit juice
Primary outcomes (1)
- measure
- Omega-3 index
- timeFrame
- 3 months
- description
- Omega-3 index is defined as % of DHA + EPA of total fatty acids in erythrocyte membranes. (DHA: Docosahexaenoic acid. EPA: Eicosapentaenoic acid).
Secondary outcomes (1)
- measure
- Adverse Events
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 2 Years
- Maximum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 2-18 years old 2. Diagnosed with and now in complete clinical remission from any type of cancer 3. Completed conventional therapy according to specific protocols within three years 4. Spoken and written Swedish is understood by caregiver and/or child 5. Expected to attend clinical follow-ups the coming three months. 6. 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. 7. Written informed consent by all caregivers and if possible by the child after 7 years of age. Exclusion Criteria: 1. Known coagulation disorder 2. Expected elective invasive surgery during the treatment 3. 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) 4. Supplementation of omega-3 during the last month 5. Regular intake of NSAIDs (nonsteroidal antiinflammatory drugs), aspirin (ASA) or vitamin D 6. Breastfeeding or pregnancy 7. Participates in other clinical trials where results may be altered by additional intervention
References
Publications (4)
- BACKGROUNDGleissman 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
- BACKGROUNDGleissman 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
- BACKGROUNDGleissman 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
- BACKGROUNDLindskog 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