AML Clinical Trial
— LUNCH1Official title:
Lipid Use, Nutrition, and Colitis in Patients With Hematological Malignancies (LUNCH1)
Verified date | July 2015 |
Source | University Hospital Inselspital, Berne |
Contact | n/a |
Is FDA regulated | No |
Health authority | Switzerland: Swissmedic |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 14 |
Est. completion date | December 2009 |
Est. primary completion date | December 2009 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Switzerland | University Hospital Inselspital | Berne |
Lead Sponsor | Collaborator |
---|---|
University Hospital Inselspital, Berne |
Switzerland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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