Pediatric CancerPhase 1OmegaChildNCT02134600
OmegaChild - Omega-3 Supplementation to Children Previously Treated for Cancer
A Phase 1 study testing Omega-3 enriched fruit juice in people with Pediatric Cancer, run by Per Kogner at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 years
- Conditions the study is for
- Pediatric Cancer
- What is being tested?
- Omega-3 enriched fruit juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSweden
- Study dates
- May 2014to 2 Sep 2016
- Phase
- Phase 1
- 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 2 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 2-18 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Childhood Cancer Research Unit, Astrid Lindgren Children´s Hospital, Karolinska Institutet
Stockholm, 17176
About this study
Official title: OmegaChild - Omega-3 Supplementation to Children Now in Full Remission From a Previous Cancer; an Early Phase Dose-finding Study.
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.
Read the detailed description
The rationale for this phase-1 trial is to find an appropriate dose of omega-3 for future phase-2 studies. The investigators aim at defining a dose that can safely be given to children previously treated for cancer, and that does not cause unacceptable side effects. In a longer perspective, randomized control trials are planned where the supplement is given for longer periods of time, and in combination with conventional cancer treatment. In preparation for these trials, this dose finding study was designed that also evaluates compliance. Subsequently the investigators hope that this supplementation can be beneficial for children during both cancer treatment and after remission.
The study population consists of children judged to be in complete clinical remission from cancer. In a phase 1 trial, one usually uses healthy individuals as study subjects, but in pediatric studies this is not allowed. Therefore patients who are in full remission were chosen as study objects, but who still come to the clinic for regular follow-ups. This group of patients is relevant for this study since it represents all ages and base-line diets, all kinds of childhood cancers, and because they have suffered from cancer and in many cases still live with the severe consequences of it.
The study is designed to give five groups of eight individuals each different doses of omega-3 adjusted to body surface area. The first group starts out on a dose of omega-3 fatty acids that is similar to the generally recommended daily intake for adults (200-400 mg). A dose escalation is then done performed group wise. The highest possible dose in this study (2 x 3000mg/day at dose level 3000 mg/m2 to a child at 1.55 m2, 3871 mg/m2) is still lower than what has previously been given as maximum to children in other studies. The investigators will keep escalating the dose level within the study only as long as no unacceptable side effects are reported.
The administration is done orally by drinking 200 mL of omega-3 supplemented fruit juice daily. It has a good fruity taste, low amounts of sugar, and no fish flavour. This should facilitate treatment compliance for the children in particular compared to when omega-3 is given in capsules - the commonest choice in other studies, but less suitable for children. Compliance is important and not further jeopardized by trying to divide the fruit juice in less amounts than the whole package, but the individually prescribed dose as well as the actual amount ingested will be recorded and exact calculations used in the analysis of the study.
All study results are primarily evaluated on an intention-to-treat basis, but will also be calculated as treated per protocol and further calculated on the exact dose consumed over 90 days given the compliance in terms of consumed number of fruit juice packages.
- Conditions
- Pediatric Cancer
- Being tested
- Omega-3 enriched fruit juice
- Keywords
- Omega-3 fatty acids, DHA, EPA, Docosahexaenoic acid, Eicosapentaenoic acid, Childhood cancer, Body composition, Inflammation, Neuropsychiatric symptoms
- Medical subject headings
- Neoplasms, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omega-3 enriched fruit juiceDietary supplement
Also called Nutrifriend by Smartfish AS
Different doses of omega-3 will be administered to five different groups:
400, 800, 1200, 2400 and 3000 mg/m2.
| Study group | Role | What they receive |
|---|---|---|
| Omega-3 enriched fruit juice | Experimental | Single arm study: Omega-3 enriched fruit juice in increasing dosage Receives: Dietary Supplement: Omega-3 enriched fruit juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months
Secondary outcomes (1)
Adverse Events
Adverse events will be graded according to NCI Common Terminology Criteria for Adverse Events (CTCAE) v.4.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2014 (estimated)
- Study startMay 2014
- Primary completionAug 2016
- Study completion2 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Per Kogner
- Sponsor type
- University, hospital or other
- Collaborators
- Smartfish AS
- Responsible party
- Sponsor-investigator, Per Kogner, Karolinska Institutet
- Investigators
- Per Kogner, Professor, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02134600
- Sponsor's protocol ID
- 20130321
- Acronym
- OmegaChild
- Status last verified
- Aug 2018
- First submitted
- 7 May 2014
- Last updated
- 28 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 20499314Gleissman 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.
PubMed 20211172Gleissman 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.
PubMed 19890019Lindskog 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.
PubMed 16353135
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OmegaChild - Omega-3 Supplementation to Children Now in Full Remission From a Previous Cancer; an Early Phase Dose-finding Study.
- ClinicalTrials.gov ID
- NCT02134600
- Acronym / sponsor ID
- OmegaChild / 20130321
- Conditions
- Pediatric Cancer
- Keywords
- Omega-3 fatty acids, DHA, EPA, Docosahexaenoic acid, Eicosapentaenoic acid, Childhood cancer, Body composition, Inflammation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Per KognerUniversity, hospital or other
- Collaborators
- Smartfish AS
- Study start
- May 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- 2 Sep 2016 (actual)
- First posted
- 9 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The rationale for this phase-1 trial is to find an appropriate dose of omega-3 for future phase-2 studies. The investigators aim at defining a dose that can safely be given to children previously treated for cancer, and that does not cause unacceptable side effects. In a longer perspective, randomized control trials are planned where the supplement is given for longer periods of time, and in combination with conventional cancer treatment. In preparation for these trials, this dose finding study was designed that also evaluates compliance. Subsequently the investigators hope that this supplementation can be beneficial for children during both cancer treatment and after remission.
The study population consists of children judged to be in complete clinical remission from cancer. In a phase 1 trial, one usually uses healthy individuals as study subjects, but in pediatric studies this is not allowed. Therefore patients who are in full remission were chosen as study objects, but who still come to the clinic for regular follow-ups. This group of patients is relevant for this study since it represents all ages and base-line diets, all kinds of childhood cancers, and because they have suffered from cancer and in many cases still live with the severe consequences of it.
The study is designed to give five groups of eight individuals each different doses of omega-3 adjusted to body surface area. The first group starts out on a dose of omega-3 fatty acids that is similar to the generally recommended daily intake for adults (200-400 mg). A dose escalation is then done performed group wise. The highest possible dose in this study (2 x 3000mg/day at dose level 3000 mg/m2 to a child at 1.55 m2, 3871 mg/m2) is still lower than what has previously been given as maximum to children in other studies. The investigators will keep escalating the dose level within the study only as long as no unacceptable side effects are reported.
The administration is done orally by drinking 200 mL of omega-3 supplemented fruit juice daily. It has a good fruity taste, low amounts of sugar, and no fish flavour. This should facilitate treatment compliance for the children in particular compared to when omega-3 is given in capsules - the commonest choice in other studies, but less suitable for children. Compliance is important and not further jeopardized by trying to divide the fruit juice in less amounts than the whole package, but the individually prescribed dose as well as the actual amount ingested will be recorded and exact calculations used in the analysis of the study.
All study results are primarily evaluated on an intention-to-treat basis, but will also be calculated as treated per protocol and further calculated on the exact dose consumed over 90 days given the compliance in terms of consumed number of fruit juice packages.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Omega-3 enriched fruit juice | Experimental | Dietary Supplement: Omega-3 enriched fruit juiceSingle arm study: Omega-3 enriched fruit juice in increasing dosage |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 2-18 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Omega-3 enriched fruit juiceAlso: Nutrifriend by Smartfish ASDifferent doses of omega-3 will be administered to five different groups: 400, 800, 1200, 2400 and 3000 mg/m2. | Dietary supplement | Omega-3 enriched fruit juice |
Primary outcome
Omega-3 index
Time frame: 3 months
Omega-3 index is defined as % of DHA + EPA of total fatty acids in erythrocyte membranes. (DHA: Docosahexaenoic acid. EPA: Eicosapentaenoic acid).
1 secondary outcome
Adverse Events
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2018.
- Background: PubMed 20499314Gleissman 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.
- Background: PubMed 20211172Gleissman 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.
- Background: PubMed 19890019Gleissman 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.
- Background: PubMed 16353135Lindskog 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per Kogner, Professor principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Omega-3 enriched fruit juice in people with Pediatric Cancer, run by Per Kogner at 1 site in Sweden.
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 7 inclusion and 7 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 28 Aug 2018. 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 Sweden. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Omega-3 index (time frame: 3 months). 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 NCT02134600, which also lists 4 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 28 Aug 2018.