Early Enteral Nutrition for Patients Undergoing Donor Stem Cell Transplantation for Hematological Malignancies
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm I (enteral nutrition) Patients receive enteral nutrition via nasoenteric feeding tube starting on day 1 until hospital discharge. |
Dietary Supplement: Nutritional Supplement Drink
Given enteral nutrition via nasoenteric feeding
Other Names:
Other: Survey Administration
Ancillary studies
|
| Active Comparator: Arm II (standard of care) Patients receive standard of care nutritional support. |
Dietary Supplement: Standard of Care Nutritional Support
Given standard of care, which may be parenteral nutrition
Other Names:
Other: Survey Administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Study participation rates [60 days following transplant]
- Compliance with randomization (Number of participants) [60 days following transplant]
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.
- Tolerance of early enteral nutrition (EN) [60 days following transplant]
Tolerance of early EN will be calculated as delivery of the intended amount on each day that nutritional supplementation was indicated.
- Level of comfort/distress attributed to EN [60 days following transplant]
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.
- Incidence of adverse events [60 days following transplant]
Will assess safety: including diarrhea, aspiration events, pneumonia, or tube misplacement.
Secondary Outcome Measures
- Number of days receiving at least 650 mL EN [60 days following transplant]
Eligibility Criteria
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
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At least 18 years of age
Exclusion Criteria:
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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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | United States | 98109 |
Sponsors and Collaborators
- Fred Hutchinson Cancer Center
Investigators
- Principal Investigator: David Fredricks, Fred Hutch/University of Washington Cancer Consortium
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RG1121363
- NCI-2021-00842
- 10599