Feasibility Study Comparing Enteral vs Parenteral Nutritional Outcomes in Autologous Stem Cell Transplant Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Feasibility Study of Nutritional Outcomes in Autologous Hematopoietic Stem Cell Transplant Recipients Comparing Enteral Nutrition Versus Parenteral Nutrition

Conditions
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Malignant Hematologic Neoplasm

Intervention / Treatment
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* Procedure: Parenteral Nutrition/Enteral Nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All adult patients aged 18 to 75 years. Patients admitted to Victoria Hospital undergoing AHSCT on C7 unit. Patient consented to participate in the study Patients diagnosed with the following conditions: Non- Hodgkin's Lymphoma (all types), Hodgkin's Lymphoma (all subtypes) and Multiple Myeloma Patients receiving any of the following: Conditioning chemotherapy: Melphalan, Etoposide/Melphalan, or Carmustine, Etoposide, Cytarabine, Melphalan Have a functional Gastrointestinal tract Exclusion Criteria: Intestinal obstruction Patients with nasal deformities, tumors of nasal tracts or upper nare obstruction. Patients with active bacteremia while proceeding with transplant Patients with active malignancy of Upper GI tract, not in remission as evidenced by recent imaging studies (< 4 weeks) Patients with any GI bleeding, paralytic ileus, obstruction, or any other GI condition which excludes use of the GI system for nutritional support as these patients will require PN feeding only and cannot be randomized

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomization will be 1:1, both EN and PN arms. The patients will be randomized in permutated blocks independently by Statistician.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Parenteral Nutrition<br>Patients who have been randomized to receive PN will be started on day 5 post AHSCT. This will be if patient intake is < 80% of usual oral intake at that time. The central venous catheter required for PN administration will be already in place for AHSCT treatment, prior to admission and pre-transplant evaluation. Nutritional support will continue until oral intake is >50% or until the patient is ready for discharge if intake remains < 50% of recommendations. | Procedure: Parenteral Nutrition/Enteral Nutrition<br>* 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.<br>|
| Experimental: Enteral Nutrition<br>Patients who have been randomized to receive EN will have a Nasogastric tube (NGT) inserted on day 5 post AHSCT, prior to start of Enteral feeds. This would be a polyurethane tube, 8-10 French, which will be inserted by physician or Nurse Practitioner with position confirmed by radiological examination. This will be if patient intake is < 80% of usual oral intake at that time. Nutritional support will continue until oral intake is >50% or until the patient is ready for discharge if intake remains < 50% of recommendations. | Procedure: Parenteral Nutrition/Enteral Nutrition<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enrollment of patients | The number of patients enrolled | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quadriceps muscle layer thickness | Maintenance and/or improvement of quadriceps muscle layer thickness (QMLT) measurement: measured by ultrasound. | 21 days | 
| Duration of Support | A comparison of duration in days a patient will require enteral or parenteral nutritional support during their admission. | 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. | 21 days | 
| Hospital Stay | Length of hospital stay (decrease by 1+/-2 days) | 21 days | 
| Mortality | Mortality on Day+30 Post AHSCT | 30 days | 
| Changes in body fat | Measuring the changes in percentage of body fat mass using Bioelectric Impedance Analysis | 21 Days | 
| Changes in Lean Muscle | Measuring the changes in percentage lean muscle mass using Bioelectric Impedance Analysis | 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 | 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. | 15 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Non- Hodgkin's Lymphoma, Hodgkin's Lymphoma, Multiple Myeloma, AHSCT