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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
First received
Last updated
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
Health authority
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. .

Study Design


Related Conditions & MeSH terms


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.
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