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

• Sponsor: M.D. Anderson Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT06004063
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 76.9
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Stem Cell	Dietary Supplement: Enteral nutrition (EN); Other: Standard care parenteral nutrition (PN)	N/A

Detailed Description

Primary Objective:

1. 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 Design

• Study Type: Interventional
• Anticipated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Supportive Care
• Official Title: Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Paranteral Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Randomized Controlled Study
• Actual Study Start Date: Aug 4, 2023
• Anticipated Primary Completion Date: Dec 31, 2027
• Anticipated Study Completion Date: Dec 31, 2029

Arms and Interventions

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.	Dietary Supplement: Enteral nutrition (EN); Given by Nasogastric Tube; Other: Standard care parenteral nutrition (PN); Given by PO or Given by IV (vein)
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)

Outcome Measures

Primary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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. .

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	M D Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• M.D. Anderson Cancer Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• M D Anderson Cancer Center

Publications

None provided.

• Responsible Party: M.D. Anderson Cancer Center
• ClinicalTrials.gov Identifier: NCT06004063
• Other Study ID Numbers: 2021-0116; NCI-2023-06448
• First Posted: Aug 22, 2023
• Last Update Posted: Aug 25, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 25, 2023