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

This study has suspended participant recruitment.
(Pre-specified interim analysis of safety and efficacy is pending.)
Sponsor:
Information provided by:
University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier:
NCT00533078
First received: September 19, 2007
Last updated: February 6, 2009
Last verified: January 2009
  Purpose

In patients with acute myelogenous leukemia (AML), a high proportion will suffer from inflammation of the large bowel (colitis) during their intensive treatment. As there is no standard treatment available for this potentially lifethreatening condition, we focus on the role of parenteral nutrition which these patients inevitably require. Preclinical and clinical data have shown strong anti-inflammatory properties of fish oil preparations containing poly-unsaturated omega3 fatty acids (PUFA) as opposed to other lipid fractions. There may be a therapeutic benefit of adding omega3 PUFA to standard nutrition in patients with chemotherapy-induced colitis. In this small phase II study, we address the effectiveness of this approach to reduce the incidence and severity of colitis in AML patients.


Condition Intervention Phase
Colitis
Mucositis
AML
Dietary Supplement: omegaven
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies (LUNCH1)

Resource links provided by NLM:


Further study details as provided by University Hospital Inselspital, Berne:

Primary Outcome Measures:
  • efficacy of an omega-3 PUFA containing lipid emulsion in reducing the incidence of °3-4 colitis (CTC AE v3.0) [ Time Frame: time to completion of cytotoxic chemotherapy ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: November 2007
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1 Dietary Supplement: omegaven
Trial participants are prescribed TPN by the attending physician as soon as indicated, which will be administered via a central venous line over a time period of approximately 20 hours per day. The formulation given to all patients is Nutriflex lipid spezial®, an emulsion containing the full supply of carbohydrates, amino acids and lipids (SO:MCT = 1:1) with a total energy content of 2215 kcal in a 1875 ml volume, see Investigator's Brochure. In addition, they receive daily infusional Omegaven® 100 ml over 4 hours, which equal FO 10 g/d or omega-3 PUFA 3-6 g/d.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 pancreatitis
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533078

Locations
Switzerland
University Hospital Inselspital
Berne, Switzerland, 3010
Sponsors and Collaborators
University Hospital Inselspital, Berne
Investigators
Principal Investigator: Johannes Bükki, MD Inselspital Berne
  More Information

No publications provided by University Hospital Inselspital, Berne

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johannes Buekki, MD, University Hospital Inselspital, Berne
ClinicalTrials.gov Identifier: NCT00533078     History of Changes
Other Study ID Numbers: 2007DR2232, 1345 (institution), 120/07 (ethics review board)
Study First Received: September 19, 2007
Last Updated: February 6, 2009
Health Authority: Switzerland: Swissmedic

Keywords provided by University Hospital Inselspital, Berne:
omega3 fatty acid
parenteral nutrition
chemotherapy
infection
neutropenia

Additional relevant MeSH terms:
Colitis
Colonic Diseases
Digestive System Diseases
Gastroenteritis
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on November 25, 2014