Early Enteral Nutrition for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies

Study Overview
=================
Brief Summary
-----------------
This clinical trial examines early enteral nutrition for patients undergoing donor stem cell transplantation for hematological malignancies. Patients undergoing donor stem cell transplantation often develop oral and gastrointestinal damage from chemotherapy, radiotherapy, or graft-versus-host disease that makes oral intake inadequate for meeting nutritional needs, especially during the catabolic period of recovery. Parenteral (intravenous) nutrition often requires a large fluid load, has been associated with increased risk of infection, can be associated with metabolic complications such as hyperglycemia and hypertriglyceridemia, is linked to elevated liver function tests, and may deprive the gastrointestinal mucosa of factors thought to promote mucosal integrity and healing. Enteral nutrition via a nasoenteric feeding tube is an alternate method of nutrition support. Giving early enteral nutrition may be more tolerable for patients undergoing a stem cell transplant.

Detailed Description
-----------------
OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge. ARM II: Patients receive standard of care nutritional support.

Official Title
-----------------
Feasibility of Implementing Early Enteral Nutrition for Patients Undergoing Allogeneic Hematopoietic Cell Transplantation for Hematological Malignancies

Conditions
-----------------
Hematopoietic and Lymphoid Cell Neoplasm

Intervention / Treatment
-----------------
* Dietary Supplement: Kate Farms 1.0
* Dietary Supplement: Standard of Care Nutritional Support
* Other: Survey Administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide written informed consent prior to initiation of any study procedures Planned myeloablative allogeneic stem cell transplantation (note, melphalan dose of 140 mg/m^2 is included) with planned hospital admission for transplant At least 18 years of age Exclusion Criteria: Major psychiatric diagnosis that impairs cognitive functioning or is not controlled at the time of the approach, as judged by the patient's medical team Currently receiving EN or parenteral nutrition (PN) Physical restrictions to the placement of a nasoenteric feeding tube

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm I (enteral nutrition)<br>Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge. | Dietary Supplement: Kate Farms 1.0<br>* Given enteral nutrition via nasoenteric feeding<br>* Other names: Polymeric Enteral Nutrition Formula;Other: Survey Administration<br>* Ancillary studies<br>|
| Active Comparator: Arm II (standard of care)<br>Patients receive standard of care nutritional support. | Dietary Supplement: Standard of Care Nutritional Support<br>* Given standard of care, which may be parenteral nutrition<br>* Other names: TPN;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study participation rates | The proportion of patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals (CI). | 90 days following transplant | 
| Compliance with randomization (Number of participants) | Medical records will be reviewed to assess compliance with the randomization, defined as receiving the assigned nutritional mode during the initial hospitalization irrespective of whether the other feeding mechanism was also used. Participants receiving both forms of nutrition will be noted. | 90 days following transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days receiving at least 650 mL EN |  | 90 days following transplant | 
| Tolerance of early enteral nutrition (EN) | Tolerance of early EN will be calculated as delivery of the intended amount on each day that nutritional supplementation was indicated. | 90 days following transplant | 
| Level of comfort/distress attributed to EN | The post-discharge questions measuring level of comfort or distress experienced with each nutritional treatment will be tabulated. The level of comfort/distress will be assessed using one scale with comfort and distress on opposite ends of a 9 point scale, 1 being comfortable and 9 being distressful. | 90 days following transplant | 
| Incidence of adverse events | Will assess safety: including diarrhea, aspiration events, pneumonia, or tube misplacement. | 90 days following transplant |