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Enteral vs Parenteral Nutrition for Stem Cell Transplant Patients

N/A

Recruiting

Led By Shehla Razvi, MD

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion; an average of 1 year.

Awards & highlights

Study Summary

This trial will test if feeding patients after stem cell transplant is safe and feasible.

Who is the study for?

This trial is for pediatric and adult patients admitted for hematopoietic stem cell transplant (HSCT). It's open to those over 2 years old but under 25 at enrollment, with consent from adults or guardians of minors. Pregnant females or patients unable to receive enteral nutrition due to certain medical conditions cannot participate.Check my eligibility

What is being tested?

The study compares the safety and practicality of feeding HSCT patients with enteral nutrition (EN) versus standard care parenteral nutrition (PN). The aim is to determine which method is more effective post-transplant in a controlled environment.See study design

What are the potential side effects?

Potential side effects may include digestive issues related to the mode of nutrition—such as discomfort, bloating, or infection at the site where nutrients are administered—and possible intolerance leading to nutritional deficiencies.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion; an average of 1 year.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion; an average of 1 year.

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion; an average of 1 year. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Enteral nutrition (EN)-Group 1Experimental Treatment2 Interventions

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.

Group II: Standard care parenteral nutrition (PN)-Group 2Active Control1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Enteral nutrition (EN)

2012

N/A

~370

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor

2,974 Previous Clinical Trials

1,789,434 Total Patients Enrolled

Shehla Razvi, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals still being enlisted for this clinical experiment?

"According to information on clinicaltrials.gov, this experiment is still recruiting candidates as of today's date. It was initially posted on August 4th 2023 and the details were most recently adjusted on August 23rd 2023."

Answered by AI

What is the optimal number of participants in this clinical experiment?

"Verified. On clinicaltrials.gov, the information shows that this research is currently in search for participants. It was first published on August 4th 2023 and edited most recently on August 23rd 2023, with an aim to recruit 40 patients from one medical centre."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2023. "Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Paranteral Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Randomized Controlled Study". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06004063.