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

Stem Cell Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06004063
• Other study ID #: 2021-0116
• Secondary ID: NCI-2023-06448
• Status: Recruiting
• Phase: N/A
• Start date: August 4, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: June 2024
• Source: M.D. Anderson Cancer Center
• Contact: Shehla Razvi, MD
• Phone: (713) 792-6635
• Email: srazvi[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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. .

Related Conditions & MeSH terms

• Stem Cell

Intervention

Dietary Supplement:
• Enteral nutrition (EN)
Given by Nasogastric Tube

Other:
• Standard care parenteral nutrition (PN)
Given by PO or Given by IV (vein)

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.

External Links

•   M D Anderson Cancer Center