Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Paranteral Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Randomized Controlled Study

The goal of this research study is to learn if feeding someone after a stem cell transplant is safe and practical.

Study Overview

• Status: Recruiting
• Conditions: Stem Cell
• Intervention / Treatment: Other: Standard care parenteral nutrition (PN); Dietary supplement: Enteral nutrition (EN)

Detailed Description

Primary Objective:

a. To determine feasibility of administering enteral nutrition (EN) via NG/GT in SCT population in peri-transplant period.

Secondary Objectives:

1. Determine the differential effects of enteral feeding versus Parenteral feeding on nutrition, and quality of life.
2. Determine the differential effects of enteral feeding versus parenteral feeding on survival and, medical comorbidities
3. Determine the differential effects of enteral feeding versus parenteral feeding on Fitbit data study for patients co-enrolled in Pediatric Energy Balance Data Repository Protocol PA18-0130.
4. Identify differential effects on microbiome for patients co-enrolled on "A Study to Collect Peripheral Blood, Tissue, and Bone Marrow samples from Donors and Recipients of blood and marrow transplants for Laboratory Research Protocol Lab99-062".
5. Determine adverse effects of enteral feeding in this population

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shehla Razvi, MD; Phone Number: (713) 792-6635; Email: srazvi@mdanderson.org
• Study Contact Backup: Name: Karen Moody, MD; Phone Number: 713-792-6610; Email: kmoody@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Contact: Shehla Razvi, MD; Phone Number: 713-792-6635; Email: srazvi@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Be admitted to an inpatient pediatric or adult ward for the purpose of HSCT.
2. Be greater than 2 years of age and less than 25 years of age at time of study enrollment.
3. Participants > 18 or guardians for participants < 18 are willing and able to give written informed consent and to comply with all of the study activities. Assent is required for children > 7 years old.
4. Participants will be encouraged to co-enroll on two additional related energy -balance protocols (highly encouraged but not required)
5. Participants will be asked to consider co-enrollment on Stem Cell Registry studies (not required):

Exclusion Criteria:

1. Patients in whom EN is contraindicated (e.g intestinal ischemia, complete bowel obstruction, or other anatomical obstructive process), or all available routes of EN are contraindicated. Surgical GT placements for the sole purpose of study participation will not be entertained.
2. Females who are pregnant. We follow FACT guidelines. Per Foundation for the Accreditation of Cellular Therapy (FACT), female patients must have a negative pregnancy test 7 days prior to bone marrow transplant. .

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Enteral nutrition (EN)-Group 1; Participants will receive enteral feeding (directly into the stomach) based on your ability to receive your daily caloric needs by mouth. Participants will be monitored by a dietician and may receive feeding by vein to achieve caloric goals.	Other: Standard care parenteral nutrition (PN); Given by PO or Given by IV (vein); Dietary supplement: Enteral nutrition (EN); Given by Nasogastric Tube
Active Comparator: Standard care parenteral nutrition (PN)-Group 2; Participants will receive the standard of care. Participants will be monitored by a dietician to see if the participants are able to receive your daily caloric needs by mouth. Some participants may be able to receive oral dietary supplements, but if this is not possible or not enough, participants will begin receiving standard of care feeding by vein.	Other: Standard care parenteral nutrition (PN); Given by PO or Given by IV (vein)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0	through study completion; an average of 1 year.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Investigators: Principal Investigator: Shehla Razvi, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029

Study Registration Dates

• First Submitted: August 15, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2021-0116; NCI-2023-06448 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No