Multicenter clinical trial of nutritional Management in Reduced-Intensity Stem Cell Transplantation from An Unrelated Donor (with or without A Liquid Diet Containing Digested-form Oligopeptide)
Phase 2
Recruiting
- Conditions
- hematological malignancies
- Registration Number
- JPRN-UMIN000003884
- Lead Sponsor
- Research supported by Ministry of Health, Labour and Welfare
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 76
Inclusion Criteria
Not provided
Exclusion Criteria
(1) Patient with severe organ dysfunction (2) Patient with the postitivity of anti-HIV antibody (3) Patient with uncontrolled infection (4) Patient with pregnancy or breast feeding (5) Patient with pshycological disease (6) Patient with allergy against the drugs which are used for allogeneic transplant including chemotherapy and GVHD prophylaxis (7) Patient with allergy against oligopeptide
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Probability of more than grade 3 intestinal toxicity up to 28 days after transplant
- Secondary Outcome Measures
Name Time Method (1) 1-year overall survival and 1-year progression-free survival (2) Total duration of more than grade 3 intestinal toxicity up to 28 days (3) Treatment-related toxicity (4) Engraftment (5) Acute GVHD (6) Infection (7) Duration of TPN (8) Dose and duration of intravenous molphine (9) Total dose of insulin (10) Hyperglycemia and hypoglycemia (11) DAO activity (12) Laboratory data (total protein, albumin, cholinesterase, pre-albumin, RBP, CRP, urinary creatinine)