OmegaChild - Omega-3 Supplementation to Children Previously Treated for Cancer
Condition: Pediatric Cancer
Study type: Interventional
Phase: Phase 1

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.
    

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.
    

Intervention name(s): Omega-3 enriched fruit juice
Intervention type(s): Dietary Supplement
Intervention description(s): Different doses of omega-3 will be administered to five different groups:
400, 800, 1200, 2400 and 3000 mg/m2.
Other intervention name(s): Nutrifriend by Smartfish AS
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Omega-3 fatty acids; DHA; EPA; Docosahexaenoic acid; Eicosapentaenoic acid; Childhood cancer; Body composition; Inflammation; Neuropsychiatric symptoms