A multi-center randomized phase II study of nutritonal support with intensive glucose control after allogeneic stem cell transplantation lipid-free vs lipid

UMIN ID: UMIN000001189

Registered date:16/06/2008

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: hematological malignancies
• Date of first enrollment: 2007/06/01
• Target sample size: 80
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Intensive Glucose control
Use of intravenous lipid formulation

Outcome(s)

• Primary Outcome: Documented infections at 100 days post-transplant
• Secondary Outcome: secondary endpoint 1.Overall survival and progression-free survival at 100 days post-transplant 2.Overall survival and progression-free survival at 1 year post-trasnplant 3.treatment-related toxicity(CTCAE ver.3.0) 4.probability and severity of GVHD 5.time to GVHD 6.time to engraftment 7.probability of engraftment 8.insulin dose 9.hyperglycemia and hypoglycemia(CTCAE ver.3.0)

Key inclusion & exclusion criteria

• Age minimum: 18years-old
• Age maximum: 60years-old
• Gender: Male and Female
• Exclude criteria: (1) CML blast crisis (2) chemotherapy-refractory ML or ATLL (3) Patient who has already received multiple allogeneic stem cell transplantation (4) Patient with active infection (5) Patient with uncontrolled CNS invasion (6) Hypertriglyceridemia (>350 mg/dL) (7) Patient with DM and with insulin therapy (8) Patient who are pregnant (9) Patient with mental disorder (10) Patient with allergy to drugs which are included in conditioning regimen or GVHD prophylaxis (11) Patient with allergy to intravenous lipid formulation or insulin

Related Information

• Primary Sponsor: National Cancer Center Hospital
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare