Enteral Nutrition for Bone Marrow Transplant

Overseen By IIT Office Clinical Trails Office

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Nebraska

Disqualifiers: Chronic gastrointestinal conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 30

Duration: Approximately 14 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether starting tube feeding (enteral nutrition) immediately after a bone marrow transplant can reduce severe gut problems. It compares two groups: one receives usual care, and the other begins tube feeding right after the transplant. Researchers aim to determine if early feeding lowers the risk of serious gut issues and improves overall recovery. Individuals with blood cancer or a serious blood disorder planning a bone marrow transplant might be suitable candidates. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that enteral nutrition is safe for patients undergoing bone marrow transplant?

Research has shown that feeding directly into the stomach or small intestine, known as enteral nutrition, is generally safe for patients undergoing bone marrow transplants. Studies suggest it might even be more beneficial than feeding through a vein, called total parenteral nutrition (TPN), because enteral nutrition is linked to a lower risk of acute graft-versus-host disease (aGvHD), where the donor's cells attack the patient's body.

Regarding safety, a small study found that enteral nutrition is safe and well-tolerated by patients undergoing stem cell transplants. Most patients handle this type of feeding well, with only mild discomfort from the feeding tube, and serious side effects are rare. Overall, enteral nutrition appears to be a promising and safe option for nutritional support in this context. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about enteral nutrition for bone marrow transplant patients because it offers a potentially safer and more natural way to support patients' nutritional needs right after the transplant. Unlike standard care, which often relies on parenteral nutrition delivered via IV, enteral nutrition uses the digestive tract, aiming to improve gut health and reduce complications. This approach could enhance recovery by promoting better nutrient absorption, maintaining gut integrity, and potentially lowering infection risks, making it a promising alternative to traditional methods.

What evidence suggests that enteral nutrition might be an effective treatment for blood cancer or serious blood disorders?

Research has shown that feeding through a tube directly into the stomach or small intestine, known as enteral nutrition, might help lower the chances of developing acute graft-versus-host disease (aGvHD). This condition occurs after a bone marrow transplant when the donor's cells attack the recipient's body. A study that combined results from multiple research papers found that enteral nutrition was linked to a lower risk of aGvHD compared to other feeding methods. While both enteral nutrition and intravenous feeding provide similar nutritional support, enteral nutrition may offer extra benefits, such as reducing infections and improving overall transplant success. In this trial, participants in the study group will receive enteral nutrition starting on day +1, while the control group will receive supplemental enteral or parenteral nutrition as clinically indicated. These findings suggest that enteral nutrition could be a promising option for people undergoing a bone marrow transplant. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael Haddadin, MD

Principal Investigator

University of Nebraska

Are You a Good Fit for This Trial?

This trial is for patients with blood cancer or serious blood disorders who are planning to undergo an allogeneic hematopoietic stem cell transplant. Participants must be suitable for any conditioning regimen or graft source and willing to start enteral nutrition post-transplant.

Inclusion Criteria

I have been diagnosed with a serious blood disorder.

I am scheduled for a stem cell transplant from a donor.

I am undergoing or have undergone a stem cell transplant.

Exclusion Criteria

I do not have any physical deformities in my nose or throat that would prevent the use of a nasogastric tube.

I have a long-term gut condition that affects food absorption or requires special nutrition.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either standard of care or enteral nutrition via feeding tube starting on day +1 post-transplant for at least 7 days, usually until engraftment

Approximately 14 days

Daily monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness, including assessments of acute GVHD, weight, lean muscle mass, and quality of life

100 days

Assessments at Day +30 and Day +100 post-transplant

What Are the Treatments Tested in This Trial?

Interventions

• Enteral Nutrition

Trial Overview

The study compares standard care with the addition of enteral nutrition via a feeding tube starting on day +1 after transplant, continuing until engraftment. It aims to see if this reduces severe gut complications by day +100 and affects other health outcomes like weight loss, muscle mass, physical function, quality of life, hospital stay length, and time to immune system recovery.

How Is the Trial Designed?

Group I: The study group (enteral nutrition starting on day +1) Experimental Treatment 1 Intervention

Group II: The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated) Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of Nebraska

Lead Sponsor

Trials

563

Recruited

1,147,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10876195/

Enteral nutrition during bone marrow transplantation in ...

The average percentage of patients with adequate energy intake was 56% in autologous and 38% in allogenic cases, which demonstrated a borderline difference.

2.

astctjournal.org

astctjournal.org/article/S2666-6367(20)30023-3/fulltext

Enteral versus Parenteral Nutrition as Nutritional Support ...

Our meta-analysis of the current studies shows that the use of enteral nutrition is associated with reduced incidence of acute graft-versus-host disease (aGvHD) ...

3.

cancer.gov

cancer.gov/research/participate/clinical-trials-search/v?id=NCI-2023-06448

Enteral Nutrition for Improving Health Outcomes in Patients ...

This study may help researchers learn whether enteral feeding after transplant may improve transplant-related health outcomes such as reduced infection, earlier ...

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0006497123136846

Enteral Versus Parenteral Nutrition in Patients Undergoing ...

This study found that enteral and parenteral nutrition provided similar levels of nutritional support, and there were no statistically significant differences ...

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04024618

Feasibility Study Comparing Enteral vs Parenteral ...

This study will highlight that Enteral Nutrition (EN) is as effective in nutritionally supporting as Parenteral Nutrition (PN) in this group of patients ...

6.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S2405457724002043

Modern views of nutritional support in patients undergoing ...

Patients undergoing allogeneic stem cell transplant (HSCT) have a higher risk of developing malnutrition. The aetiology is multifactorial and complex: the ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06004063

Safety, Tolerability, and Efficacy of Enteral Nutrition Versus ...

Safety, Tolerability, and Efficacy of Enteral Nutrition Versus Standard of Care Nutrition in Hematopoietic Stem Cell Transplant Patients: A Pilot Study.