This study will highlight that Enteral Nutrition (EN) is as effective in nutritionally supporting as Parenteral Nutrition (PN) in this group of patients undergoing an autologous hematopoietic stem cell transplantation (AHSCT). The rationale of this study is to compare nutritional, medical, cost and Quality of Life (QOL) outcomes in patients receiving either EN or PN nutritional support in patients. The main outcomes are to examine are nutritional status, medical complications, cost and QOL before and after AHSCT.
This will be a pilot open randomized study. The study will be conducted at the inpatient setting at London Health Sciences Centre in London, ON. Forty patients will be randomized in permutated blocks independently by Statistician, to either the EN or PN group on admission to the unit. The baseline evaluations are blood work, Bioelectric Impedance Analysis (BIA), Subjective Global Assessment (SGA), Body Mass Index (BMI) calculation, ultrasound, and a medical evaluation. Patients do have the right to refuse either or both types of nutritional support. As part of standard care, the risks and benefits of nutritional support for both EN and PN will be explained to the patient. Consent will be obtained prior to admission. Most of these patients initially continue to maintain their oral intake even after chemotherapy. On Day 5+/- 1 day after transplantation, the randomized nutrition therapy will only be initiated only if patient intake is \< 80% of usual intake, where they will be provided with 25-35 kcal/kg/day, 1.2-1.5g of protein/kg/day, and omega-3 to supplement any oral intake the patient might not have. If the intake is \>80% of required intake, initiation of randomized therapy will only happen on the day the intake falls to \<80% of required nutritional intake. Patients will be monitored until Day 15 where post-transplant evaluations will be conducted: blood work, BIA, SGA, ultrasound, BMI, food records, and medical evaluation. If at that time, patients are not consuming 50% of energy from oral feeds, nutrition therapy will continue until oral goal is met or until discharge for medical reasons. Patients will be assessed at Day+30 post-transplant in clinic and the following will be completed blood work, BIA, SGA, BMI, food records, ultrasound, medical complications and a QOL assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Patients randomized to the parenteral nutrition arm will receive nutrition by IV and patients randomized to the enteral nutrition arm will receive nutrition by NG tube.
London Health Sciences Centre-Victoria Hospital
London, Ontario, Canada
RECRUITINGEnrollment of patients
The number of patients enrolled
Time frame: 30 days
quadriceps muscle layer thickness
Maintenance and/or improvement of quadriceps muscle layer thickness (QMLT) measurement: measured by ultrasound.
Time frame: 21 days
Duration of Support
A comparison of duration in days a patient will require enteral or parenteral nutritional support during their admission.
Time frame: 21 days
Changes in costs
The cost of daily total PN is $80/day and cost of EN feeds would be $40/day. This is a 50% change in costs.
Time frame: 21 days
Hospital Stay
Length of hospital stay (decrease by 1+/-2 days)
Time frame: 21 days
Mortality
Mortality on Day+30 Post AHSCT
Time frame: 30 days
Changes in body fat
Measuring the changes in percentage of body fat mass using Bioelectric Impedance Analysis
Time frame: 21 Days
Changes in Lean Muscle
Measuring the changes in percentage lean muscle mass using Bioelectric Impedance Analysis
Time frame: 21 Days
Changes in costs to hospital when using enteral nutritional
the measurement the length of their stay in the hospital by days, fewer days of hospitalization = lower costs and more days of hospitalization = greater costs
Time frame: 21 Days
Transition from EN to oral feeding
Successful transition from EN to oral feeding versus Parenteral Nutrition to oral feeding defined by 50% oral intake on Day+15 of AHSCT.
Time frame: 15 Days
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