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Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies (LUNCH1)

Phase 2
18 Years
Not Enrolling
Colitis, Mucositis, AML

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Trial Information

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

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.

Inclusion Criteria:

- All of the following:

Subjects with a cyto- or histopathologically confirmed diagnosis of newly diagnosed:

- AML or

- biphenotypic acute leukemia with predominantly myeloid features undergoing
myeloablative treatment analogous to AML or

- refractory anemia with excess of blasts (RAEB) or refractory anemia with excess of
blasts in transformation (RAEB-t) with an IPSS score of >1.5 (appendix 10.8.) and

- ECOG performance status (PS) £2 (see appendix 10.2.) and

- Written informed consent

Exclusion Criteria:

One or more of the following:

- Contraindication to myeloablative chemotherapy, intravenous lipids, or TPN

- Previous or concomitant chronic inflammatory bowel disease, unspecified colitis or

- Impaired hepatic or renal function as defined by:

- ALAT and/or ASAT >3 x upper normal limit (UNL) and/or Bilirubin >3 x UNL unless
increase is most likely caused by AML organ infiltration

- Serum creatinin >3 x UNL (after adequate hydration), unless increase is most
likely caused by AML organ infiltration

- Other concurrent severe and/or uncontrolled medical condition

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

efficacy of an omega-3 PUFA containing lipid emulsion in reducing the incidence of °3-4 colitis (CTC AE v3.0)

Outcome Time Frame:

time to completion of cytotoxic chemotherapy

Safety Issue:


Principal Investigator

Johannes Bükki, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Inselspital Berne


Switzerland: Swissmedic

Study ID:




Start Date:

November 2007

Completion Date:

December 2009

Related Keywords:

  • Colitis
  • Mucositis
  • AML
  • omega3 fatty acid
  • parenteral nutrition
  • chemotherapy
  • infection
  • neutropenia
  • Colitis
  • Mucositis
  • Hematologic Neoplasms