NCT00533078

Brief Summary

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, the investigators 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, the investigators address the effectiveness of this approach to reduce the incidence and severity of colitis in AML patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2007

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

July 23, 2015

Status Verified

July 1, 2015

Enrollment Period

2.1 years

First QC Date

September 19, 2007

Last Update Submit

July 22, 2015

Conditions

ColitisMucositisAML

Keywords

omega3 fatty acidparenteral nutritionchemotherapyinfectionneutropenia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

1

OTHER
Dietary Supplement: omegaven

Interventions

omegavenDIETARY_SUPPLEMENT

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.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Inselspital

Bern, 3010, Switzerland

Location

Related Publications (1)

  • Bukki J, Stanga Z, Tellez FB, Duclos K, Kolev M, Krahenmann P, Pabst T, Iff S, Juni P. Omega-3 poly-unsaturated fatty acids for the prevention of severe neutropenic enterocolitis in patients with acute myeloid leukemia. Nutr Cancer. 2013;65(6):834-42. doi: 10.1080/01635581.2013.801998.

    PMID: 23909727DERIVED

MeSH Terms

Conditions

ColitisMucositisHyperphagiaInfectionsNeutropenia

Interventions

fish oil triglycerides

Condition Hierarchy (Ancestors)

GastroenteritisGastrointestinal DiseasesDigestive System DiseasesColonic DiseasesIntestinal DiseasesMouth DiseasesStomatognathic DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsAgranulocytosisLeukopeniaCytopeniaHematologic DiseasesHemic and Lymphatic DiseasesLeukocyte Disorders

Study Officials

  • Johannes Bükki, MD

    Inselspital Berne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 21, 2007

Study Start

November 1, 2007

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

July 23, 2015

Record last verified: 2015-07

Locations

CH(1)