Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies (LUNCH1)
Experimental and clinical data attribute multiple anti-inflammatory effects to a diet
enriched in omega-3 PUFA containing oils, mainly FO. These effects are mediated by their
active metabolites, the EPA- and DHA-derived eicosanoids, which antagonize the predominantly
pro-inflammatory derivates of omega-6 PUFA origin. In cardiovascular disease these data are
supported by several large-scale trials, but there also is growing evidence of beneficial
effects of an omega-3 PUFA rich diet in GI conditions such as postoperative trauma and
inflammatory bowel disease. AML patients with neutropenic colitis suffer from a condition
which is pathophysiologically closely related to the studied diseases. It is therefore
reasonable to raise the question whether this cohort would equally benefit from a novel
nutritional regimen enriched in omega-3 PUFA.
The proposed pilot study will address the question of the clinical value of adding an
omega-3 PUFA containing lipid emulsion to the TPN regimen as regards protection against
colitis ≥ °3 (primary objective). A numerical cutoff will be provided to support the
decision whether further investigation is warranted or the intervention is considered not
promising.
Target accrual is n=35 patients receiving TPN. An interim analysis will be performed after
n1=13 patients will be evaluable for the primary endpoint. The results of this interim
analysis will determine whether continuation of the trial is of interest or the trial be
stopped. The sample size has been calculated by the use of Simon's two-stage minimax design.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
efficacy of an omega-3 PUFA containing lipid emulsion in reducing the incidence of °3-4 colitis (CTC AE v3.0)
time to completion of cytotoxic chemotherapy
No
Johannes Bükki, MD
Principal Investigator
Inselspital Berne
Switzerland: Swissmedic
2007DR2232
NCT00533078
November 2007
December 2009
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