Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)Phase 2NCT07315165
Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation
A Phase 2 study testing Enteral Nutrition in people with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT), run by University of Nebraska at 1 site in United States.
Trial summary
This is a randomized controlled phase II trial which will enroll 112 patients with a diagnosis of a blood cancer or a serious blood disorder who plan to undergo an allogenic hematopoietic stem cell transplant using any conditioning regimen or graft source. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)
- What is being tested?
- Enteral Nutrition
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jul 2026to May 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of a hematological condition or serious blood disorder
- Patient planned for an allogeneic hematopoietic stem cell transplant
- Any conditioning regimen or graft source
Who cannot join
- Uncorrected anatomical deformity of the nose, nasopharynx, esophagus, or stomach that could prevent proper placement of a nasogastric tube.
- Chronic gastrointestinal conditions causing malabsorption or need for nutritional supplementation, e.g., celiac disease, short gut syndrome, chronic use of total parental nutrition or enteral nutrition for 3 or more months. Uncorrected anatomical deformity may include any known significant deviated nasal septum, large nasal polyps or other masses, or nasal or oropharyngeal trauma.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Fred & Pamela Buffet Cancer Center
Omaha, Nebraska, 68198
Michael Haddadin, MD, (402) 5593848, mihaddadin@unmc.edu
About this study
Official title: A Phase II Randomized Trial of Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation
This is a randomized controlled phase II trial which will enroll 112 patients with a diagnosis of a blood cancer or a serious blood disorder who plan to undergo an allogenic hematopoietic stem cell transplant using any conditioning regimen or graft source. Eligible patients will be randomized to receive standard of care (e.g., initiation of supplemental nutrition when oral intake declines) versus enteral nutrition via enteral feeding tube starting on day +1 post-transplant for at least 7 days, usually until engraftment.
Read the detailed description
This is a randomized controlled phase II trial which will enroll 112 patients with a diagnosis of a blood cancer or a serious blood disorder who plan to undergo an allogenic hematopoietic stem cell transplant using any conditioning regimen or graft source. Eligible patients will be randomized to receive standard of care (e.g., initiation of supplemental nutrition when oral intake declines) versus enteral nutrition via enteral feeding tube starting on day +1 post-transplant for at least 7 days, usually until engraftment. The primary endpoint will be cumulative incidence of stage 3-4 acute GVHD of the lower gut by day +100 post-transplant, whereas secondary endpoints will be stage 2-4 acute GVHD of the lower gut by day +100, grade 2-4 acute GVHD, weight loss and changes in lean muscle mass, changes in physical function, health-related quality of life, length of transplant hospital stay, and time to platelet and neutrophil engraftment. Assessments will include acute GVHD assessments and grading, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Fried Frailty Index, and Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT).
- Being tested
- Enteral Nutrition
- Keywords
- Enteral Nutrition, Acute GVHD, Stage 3-4, Stage 2-4 Gut GVHD, Nutritional Support, allo-HSCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enteral NutritionDietary supplement
A commercially available blenderized tube feed nutrition (BTF) formula will be initiated at a fixed starting rate of 25 ml/hr. The infusion rate will be increased in consultation with a registered dietitian nutritionist (RDN) based on tolerance to reach a feeding goal of 30-35 kcal/kg/day, which includes 1.5-2 g of protein/kg/day.
| Study group | Role | What they receive |
|---|---|---|
| The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated) | Active comparator | Subjects randomized to the control group with preserved oral intake will initiate conventional oral nutrition as tolerated. The dietary regimen is composed of a balanced general diet. Early supplemental nutrition will not be initiated in patients with the control group who are maintaining adequate oral intake. Receives: Dietary Supplement: Enteral Nutrition |
| The study group (enteral nutrition starting on day +1) | Experimental | The study group will start blenderized nutrition formula supplementation via enteral feeding tube on day +1 after transplant. Receives: Dietary Supplement: Enteral Nutrition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Stage 3-4 Acute GVHD of Lower Gut
Cumulative incidence will be calculated as the time to stage 3-4 acute GVHD of the lower gut for each of the study arms.
Measured: 100 Days post- transplant
Secondary outcomes (10)
Incidence of Stage 2-4 Acute GVHD of Lower Gut
Cumulative incidence will be calculated as the time to stage 2-4 acute GVHD of the lower gut for each of the study arms
Measured: 100 Days post- transplant
Percent change in weight
Percent change from baseline weight at day +30 and day +100 post-transplant.
Measured: Day +30 and Day +100 post-transplant
Percent change in lean body mass
Percent change in total lean body mass measured by DEXA scan at baseline and day +30 post-transplant.
Measured: Baseline and Day +30 post-transplant
Health-Related Quality of Life (HRQoL)
Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT), total score range 0-148, where higher scores indicate better quality of life.
Measured: Baseline and Day +100 post-transplant
Transplant hospital stay
Median duration of transplant hospital stay compared between groups.
Measured: Up to approximately 30 Days Post Transplant
Platelet and neutrophil engraftment
Cumulative incidence curves of platelet engraftment and neutrophil engraftment will be generated using the methods of Gray to adjust for the competing risk of death to determine the probabilities of neutrophil and platelet engraftment.
Measured: Aproximately14 days post-transplant
Fried Frailty Index score
Fried Frailty Index score ranges from 0 to 5, where higher scores indicate greater frailty (worse functional status).
Measured: Day +30, and Day +100 post-transplant
Activities of Daily Living (ADL)
Change in Activities of Daily Living (ADL) score from baseline to Day +30 and Day+100 post-transplant.
The ADL scale ranges from 0 to 6, where higher scores indicate greater independence (better functional status).
Measured: Day +30, and Day +100 post-transplant
Instrumental Activities of Daily Living (IADL)
Change in Instrumental Activities of Daily Living (IADL) score from baseline to Day +30 and Day +100 post - transplant.
The IADL score ranges from 0 to 8, where higher scores indicate greater independence (better functional status).
Measured: Day +30, and Day +100 post-transplant
Karnofsky Performance Scale
Karnofsky Performance Scale ranges from 0 to 100, where higher scores indicate better functional status.
Measured: Day +30, and Day +100 post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start22 Jul 2026
- Primary completionOct 2030 (estimated)
- Study completionMay 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)Studies of the same condition, open and under way.
- More trials run by University of NebraskaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All patients in both arms will receive nutrition counseling regarding the use of a high-protein, high-energy diet with snacks and high-protein supplement drinks, as tolerated. Two groups will be randomized, one receiving standard of care and the other receiving eteral nutrition via nasogastric tube. Outcomes will be compared between the two groups. In the study group, enteral nutrition will be administered, starting on allo-HSCT day +1 (the day after the infusion of stem cell transplant). Enteral nutrition will be administered through an enteral nutrition tube; the most commonly used equipment is a nasogastric tube of 8-10 Fr gauge.
- Masking
- None (open label)
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nebraska
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Haddadin, MD, Principal investigator, University of Nebraska
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315165
- Sponsor's protocol ID
- 213-26-FB
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomized Trial of Enteral Nutrition Versus Standard of Care in Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT07315165
- Acronym / sponsor ID
- 213-26-FB
- Keywords
- Enteral Nutrition, Acute GVHD, Stage 3-4, Stage 2-4 Gut GVHD, Nutritional Support, allo-HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of NebraskaUniversity, hospital or other
- Study start
- 22 Jul 2026 (actual)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- May 2031 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized controlled phase II trial which will enroll 112 patients with a diagnosis of a blood cancer or a serious blood disorder who plan to undergo an allogenic hematopoietic stem cell transplant using any conditioning regimen or graft source. Eligible patients will be randomized to receive standard of care (e.g., initiation of supplemental nutrition when oral intake declines) versus enteral nutrition via enteral feeding tube starting on day +1 post-transplant for at least 7 days, usually until engraftment.
Detailed description
This is a randomized controlled phase II trial which will enroll 112 patients with a diagnosis of a blood cancer or a serious blood disorder who plan to undergo an allogenic hematopoietic stem cell transplant using any conditioning regimen or graft source. Eligible patients will be randomized to receive standard of care (e.g., initiation of supplemental nutrition when oral intake declines) versus enteral nutrition via enteral feeding tube starting on day +1 post-transplant for at least 7 days, usually until engraftment. The primary endpoint will be cumulative incidence of stage 3-4 acute GVHD of the lower gut by day +100 post-transplant, whereas secondary endpoints will be stage 2-4 acute GVHD of the lower gut by day +100, grade 2-4 acute GVHD, weight loss and changes in lean muscle mass, changes in physical function, health-related quality of life, length of transplant hospital stay, and time to platelet and neutrophil engraftment. Assessments will include acute GVHD assessments and grading, Activities of Daily Living (ADL), Instrumental Activities of Daily Living (IADL), Fried Frailty Index, and Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All patients in both arms will receive nutrition counseling regarding the use of a high-protein, high-energy diet with snacks and high-protein supplement drinks, as tolerated. Two groups will be randomized, one receiving standard of care and the other receiving eteral nutrition via nasogastric tube. Outcomes will be compared between the two groups. In the study group, enteral nutrition will be administered, starting on allo-HSCT day +1 (the day after the infusion of stem cell transplant). Enteral nutrition will be administered through an enteral nutrition tube; the most commonly used equipment is a nasogastric tube of 8-10 Fr gauge.
| Arm | Type | Receives |
|---|---|---|
| The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated) | Active comparator | Dietary Supplement: Enteral NutritionSubjects randomized to the control group with preserved oral intake will initiate conventional oral nutrition as tolerated. The dietary regimen is composed of a balanced general diet. Early supplemental nutrition will not be initiated in patients with the control group who are maintaining adequate oral intake. |
| The study group (enteral nutrition starting on day +1) | Experimental | Dietary Supplement: Enteral NutritionThe study group will start blenderized nutrition formula supplementation via enteral feeding tube on day +1 after transplant. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of a hematological condition or serious blood disorder
- Patient planned for an allogeneic hematopoietic stem cell transplant
- Any conditioning regimen or graft source
Key exclusion criteria (2 listed)
- Uncorrected anatomical deformity of the nose, nasopharynx, esophagus, or stomach that could prevent proper placement of a nasogastric tube.
- Chronic gastrointestinal conditions causing malabsorption or need for nutritional supplementation, e.g., celiac disease, short gut syndrome, chronic use of total parental nutrition or enteral nutrition for 3 or more months. Uncorrected anatomical deformity may include any known significant deviated nasal septum, large nasal polyps or other masses, or nasal or oropharyngeal trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enteral NutritionA commercially available blenderized tube feed nutrition (BTF) formula will be initiated at a fixed starting rate of 25 ml/hr. The infusion rate will be increased in consultation with a registered dietitian nutritionist (RDN) based on tolerance to reach a feeding goal of 30-35 kcal/kg/day, which includes 1.5-2 g of protein/kg/day. | Dietary supplement | The control (initiation of supplemental enteral or parenteral nutrition as clinically indicated), The study group (enteral nutrition starting on day +1) |
Primary outcome
Incidence of Stage 3-4 Acute GVHD of Lower Gut
Time frame: 100 Days post- transplant
Cumulative incidence will be calculated as the time to stage 3-4 acute GVHD of the lower gut for each of the study arms.
10 secondary outcomes
Incidence of Stage 2-4 Acute GVHD of Lower Gut
Time frame: 100 Days post- transplant
Percent change in weight
Time frame: Day +30 and Day +100 post-transplant
Percent change in lean body mass
Time frame: Baseline and Day +30 post-transplant
Health-Related Quality of Life (HRQoL)
Time frame: Baseline and Day +100 post-transplant
Transplant hospital stay
Time frame: Up to approximately 30 Days Post Transplant
Platelet and neutrophil engraftment
Time frame: Aproximately14 days post-transplant
Fried Frailty Index score
Time frame: Day +30, and Day +100 post-transplant
Activities of Daily Living (ADL)
Time frame: Day +30, and Day +100 post-transplant
Instrumental Activities of Daily Living (IADL)
Time frame: Day +30, and Day +100 post-transplant
Karnofsky Performance Scale
Time frame: Day +30, and Day +100 post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael Haddadin, MD principal investigator
University of Nebraska
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Enteral Nutrition in people with Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT), run by University of Nebraska at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Krishna vamsi Gottipati, MS ((402) 5593518, krgottipati@unmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Stage 3-4 Acute GVHD of Lower Gut (time frame: 100 Days post- transplant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.