Enteral vs Parenteral Nutrition for Stem Cell Transplant Patients

Overseen By Karen Moody, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pregnancy, Intestinal ischemia, Bowel obstruction, others

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

Compensation: Varies

Number of Visits: Unknown

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if feeding through the stomach (enteral nutrition) is safe and practical for individuals who have undergone a stem cell transplant. It compares two methods: enteral nutrition, where food is delivered directly into the stomach, and the standard care method, parenteral nutrition, where nutrients are administered through a vein. The trial seeks participants who are planning to undergo or are currently admitted for stem cell transplants and who can speak English, Italian, Chinese/Mandarin, or Spanish. As an unphased trial, this study provides participants the chance to contribute to significant research that could enhance nutritional care for future stem cell transplant patients.

Will I have to stop taking my current medications?

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that feeding through a tube directly into the stomach, known as enteral nutrition, is generally safe for patients who have had stem cell transplants. Studies indicate that this method can lead to fewer problems compared to feeding through the veins, called parenteral nutrition. Specifically, enteral nutrition is linked to a lower risk of developing acute graft-versus-host disease, a common issue after transplants. Additionally, patients usually handle enteral feeding well without major side effects.

In contrast, parenteral nutrition, while a standard care option, carries some risks. It can lead to infections, high blood sugar, and potential liver issues. However, it remains an important option for those who cannot receive enough nutrition through enteral feeding.

Overall, both feeding methods are considered safe, but enteral nutrition might offer extra benefits by reducing complications. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether enteral nutrition, which provides nutrients directly to the stomach, might be more beneficial than the current standard of care, parenteral nutrition, which delivers nutrients through the veins. Enteral nutrition is thought to better mimic natural eating, potentially leading to improved gut health and nutrient absorption, which are vital for recovery in stem cell transplant patients. Additionally, it may reduce the risk of infection associated with intravenous feeding, offering a safer alternative. This trial could fundamentally shift how nutritional support is provided to patients undergoing stem cell transplants.

What evidence suggests that this trial's treatments could be effective for stem cell transplant patients?

This trial will compare enteral nutrition with standard care parenteral nutrition for stem cell transplant patients. Research has shown that feeding directly into the stomach (enteral nutrition) can be as effective as feeding through a vein (parenteral nutrition) for these patients. Previous studies found that enteral nutrition meets nutritional needs as well as parenteral nutrition. Patients who received enteral nutrition had similar health and nutrition outcomes compared to those who received parenteral nutrition. However, some studies observed more weight loss in patients using enteral nutrition. Overall, enteral nutrition is considered a safe and cost-effective choice for patients after stem cell transplants. ^{2 3 6 7 8}

Who Is on the Research Team?

Shehla Razvi, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am open to joining two more studies related to energy balance.

I am between 2 and 25 years old.

I am admitted to the hospital for a stem cell transplant.

Exclusion Criteria

I cannot have tube feeding due to certain health issues.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Peri-transplant Nutrition

Participants receive either enteral or parenteral nutrition during the peri-transplant period, monitored by a dietician to meet caloric needs.

4-6 weeks

Follow-up

Participants are monitored for safety, nutrition, quality of life, survival, and adverse effects after the nutrition intervention.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Enteral nutrition
• Standard care parenteral nutrition

Trial Overview 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.

How Is the Trial Designed?

Group I: Enteral nutrition (EN)-Group 1 Experimental Treatment 2 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 2 Active Control 1 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.

Enteral nutrition is already approved in European Union, United States, Canada, Japan, China, Switzerland for the following indications:

Approved in European Union as Enteral nutrition for:

• Malnutrition
• Dysphagia
• Critical illnesses
• Surgical recovery
• Cancer treatment

Approved in United States as Enteral nutrition for:

• Malnutrition
• Dysphagia
• Critical illnesses
• Surgical recovery
• Cancer treatment
• Hematopoietic stem cell transplant recovery

Approved in Canada as Enteral nutrition for:

• Malnutrition
• Dysphagia
• Critical illnesses
• Surgical recovery
• Cancer treatment

Approved in Japan as Enteral nutrition for:

• Malnutrition
• Dysphagia
• Critical illnesses
• Surgical recovery
• Cancer treatment

Approved in China as Enteral nutrition for:

• Malnutrition
• Dysphagia
• Critical illnesses
• Surgical recovery
• Cancer treatment

Approved in Switzerland as Enteral nutrition for:

• Malnutrition
• Dysphagia
• Critical illnesses
• Surgical recovery
• Cancer treatment

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Published Research Related to This Trial

In a study of 61 patients undergoing autologous hematopoietic stem cell transplantation, total parenteral nutrition (TPN) was associated with delayed platelet engraftment and increased platelet transfusion requirements compared to partial parenteral nutrition (PPN).

Patients receiving TPN also experienced higher rates of infections and elevated blood sugar levels, suggesting that TPN may not be the best nutritional support option for these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total parenteral nutrition delays platelet engraftment in patients who undergo autologous hematopoietic stem cell transplantation. Cetin, T., Arpaci, F., Dere, Y., et al.[2019]

Patients undergoing chemotherapy can tolerate tube feeding well, suggesting that enteral nutrition is a viable option during treatment despite concerns about the alimentary tract.

Enteral hyperalimentation is more physiologic, safer, and cost-effective compared to parenteral nutrition, and it can largely meet the nutritional needs of patients, although further research is needed to understand its impact on tumor metabolism and chemotherapy outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tube feeding of cancer patients treated with chemotherapy. de Vries, EG., Kreumer, WM., Schippers, DL., et al.[2019]

Tube feeding and conventional oral diets with intravenous dextrose (standard care) are associated with a significantly lower risk of infection compared to parenteral nutrition, based on a meta-analysis of 27 studies involving 1828 patients.

In malnourished populations, standard care may lead to a higher risk of mortality and a trend towards increased infection risk compared to parenteral nutrition, highlighting the need for careful nutritional management in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enteral compared with parenteral nutrition: a meta-analysis. Braunschweig, CL., Levy, P., Sheean, PM., et al.[2022]

The C+SCAV conditioning regimen for autologous stem cell transplantation in non-Hodgkin's lymphoma patients showed similar survival rates compared to the SEAM regimen, with a 1-year overall survival of 100% for C+SCAV and 95.2% for SEAM.

C+SCAV significantly reduced the incidence of serious non-hematological adverse events (10.5% vs. 40.5% in SEAM) and severe mucositis (5.3% vs. 31.0% in SEAM), making it a safer alternative for patients undergoing treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A comparison of C+SCAV and SEAM conditioning regimens in efficacy and safety in autologous hematopoietic stem cell transplantation for non-Hodgkin's lymphoma patients]. Li, JQ., Zhang, Y., Geng, HZ., et al.[2023]

In a study of 257 patients who underwent non-T-cell-depleted allogeneic stem cell transplantation, 19 patients developed post-transplant lymphoproliferative disorder (PTLD), indicating a significant risk associated with immunosuppressive treatment.

The occurrence of PTLD was strongly linked to the intensity of immunosuppressive therapy, particularly in patients who received antithymocyte globulin (ATG) during conditioning or for treating acute graft-versus-host disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

High incidence of PTLD after non-T-cell-depleted allogeneic haematopoietic stem cell transplantation as a consequence of intensive immunosuppressive treatment. Juvonen, E., Aalto, SM., Tarkkanen, J., et al.[2021]

In a study of 57 bone marrow transplant recipients, individualized enteral feeding was found to be as effective as total parenteral nutrition (TPN) in maintaining body composition during recovery, with significant cost savings since TPN was 2.3 times more expensive.

TPN was associated with more complications, such as increased diuretic use and hyperglycemia, suggesting that it may not be the best option for all patients, and should be reserved for those who cannot tolerate enteral feeding.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nutritional support of bone marrow transplant recipients: a prospective, randomized clinical trial comparing total parenteral nutrition to an enteral feeding program. Szeluga, DJ., Stuart, RK., Brookmeyer, R., et al.[2007]

In a study of 228 pediatric patients who underwent hematopoietic stem cell transplantation (HSCT), total parenteral nutrition (TPN) was used in 63.2% of cases, and was associated with a higher incidence of severe mucositis and sinusoidal obstruction syndrome (SOS) compared to enteral nutrition (EN).

While TPN was linked to increased complications like acute graft-versus-host disease (aGVHD), there were no significant differences in overall survival or chronic GVHD between TPN and non-TPN patients, highlighting the need for careful consideration of nutritional support methods post-HSCT.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The outcome and complications of total parenteral nutrition in pediatric hematopoietic stem cell transplantation. Alsalamah, S., Alramyan, R., Alakel, R., et al.[2022]

Total body irradiation (TBI) can be safely administered to pediatric patients in an outpatient setting, as demonstrated in a study of 10 children aged 9 to 17 undergoing stem cell transplantation.

The outpatient approach not only effectively managed side effects like nausea with minimal hospital admissions but also resulted in significant cost savings of approximately $2400 per patient compared to inpatient treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient total body irradiation for pediatric patients undergoing stem cell transplantation. Dagher, R., Robertson, KA., Lucas, KG., et al.[2004]

The CHOP chemotherapy regimen used for treating post-transplant lymphoproliferative disease (PTLD) is associated with significant long-term health risks, including cardiac toxicity, hormone deficiencies, secondary leukemia, and osteonecrosis, affecting a high percentage of pediatric patients.

There is a dose-dependent increase in the risk of these long-term consequences, highlighting the urgent need for safer and more effective treatment options for PTLD that minimize these adverse effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of the risks of long-term consequences associated with components of the CHOP chemotherapy regimen. Watson, C., Gadikota, H., Barlev, A., et al.[2022]

In a study of 121 patients undergoing allogeneic stem-cell transplantation, those who received enteral nutrition (EN) showed significantly better overall survival and faster engraftment of neutrophils and platelets compared to those who did not receive EN.

Enteral nutrition was found to be protective against severe acute graft-versus-host disease (aGVHD), suggesting that it is a safer and more effective option than parenteral nutrition (PN) for malnourished patients after myeloablative conditioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Better outcome of patients undergoing enteral tube feeding after myeloablative conditioning for allogeneic stem cell transplantation. Seguy, D., Duhamel, A., Rejeb, MB., et al.[2012]

In a study of 24 liver transplant patients, early enteral feeding initiated within 18 hours post-surgery was found to be well-tolerated and equally effective as total parenteral nutrition in maintaining nutritional status.

Enteral feeding may offer advantages over total parenteral nutrition, including reduced complications and costs, while ensuring that patients maintain their nutritional requirements after surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of enteral feeding and total parenteral nutrition after liver transplantation. Wicks, C., Somasundaram, S., Bjarnason, I., et al.[2019]

Enteral nutrition, particularly with glutamine supplementation, is well tolerated in children undergoing intensive chemotherapy and is significantly less expensive than total parenteral nutrition (TPN), costing less than one third of TPN.

TPN, while beneficial for some patients, is associated with higher risks of infections and gastrointestinal issues, suggesting that enteral nutrition may offer a safer and more cost-effective alternative that also supports intestinal health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glutamine-supplemented tube feedings versus total parenteral nutrition in children receiving intensive chemotherapy. Ford, C., Whitlock, JA., Pietsch, JB.[2017]

Outpatient total body irradiation (TBI) was safely administered to 142 patients, with no need for inpatient admission during treatment, demonstrating the feasibility of outpatient care in this setting.

The study found no significant difference in 100-day mortality rates between outpatient (9%) and inpatient (16%) TBI patients, indicating that outpatient TBI can be as safe as inpatient care while saving 206 inpatient days.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Outpatient total body irradiation as a component of a comprehensive outpatient transplant program. Bredeson, C., Perry, G., Martens, C., et al.[2006]

Citations

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Enteral nutrition during bone marrow transplantation in ... The average adequacy of energy intake only with tube feeding was 51% for the whole group: 56% versus 38% for the autologous and allogenic cases, respectively (P ...

2. 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 ...

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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 ...

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Enteral Versus Parenteral Nutrition in Patients Undergoing ... Meta-analysis results showed that patients receiving enteral nutrition had a higher degree of weight loss compared to those receiving parenteral ...

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Medical and Nutritional Outcomes Are Similar Among ... EN is a safe, convenient, and cost‐effective option for AHSCT patients since medical and nutritional outcomes were similar between those receiving EN compared ...

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Safety, Tolerability, and Efficacy of Enteral Nutrition Versus ... The goal of this research study is to learn if feeding someone after a stem cell transplant is safe and practical. Detailed Description. Primary Objective: a.

7. 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 ...

8. 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) ...