Allogeneic Hematopoietic Stem Cell Transplant (Allo-HSCT)
Conditions
Keywords
Enteral Nutrition, Acute GVHD, Stage 3-4, Stage 2-4 Gut GVHD, Nutritional Support, allo-HSCT
Brief 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. 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).
Interventions
DIETARY_SUPPLEMENTEnteral Nutrition
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.
Sponsors
University of Nebraska
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of a hematological condition or serious blood disorder * Patient planned for an allogeneic hematopoietic stem cell transplant * Any conditioning regimen or graft source
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Stage 3-4 Acute GVHD of Lower Gut | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Stage 2-4 Acute GVHD of Lower Gut | 100 Days post- transplant | Cumulative incidence will be calculated as the time to stage 2-4 acute GVHD of the lower gut for each of the study arms |
| Percent change in weight | Day +30 and Day +100 post-transplant | Percent change from baseline weight at day +30 and day +100 post-transplant. |
| Percent change in lean body mass | Baseline and Day +30 post-transplant | Percent change in total lean body mass measured by DEXA scan at baseline and day +30 post-transplant. |
| Health-Related Quality of Life (HRQoL) | Baseline and Day +100 post-transplant | Functional Assessment of Cancer Therapy - Bone Marrow Transplant (FACT-BMT), total score range 0-148, where higher scores indicate better quality of life. |
| Transplant hospital stay | Up to approximately 30 Days Post Transplant | Median duration of transplant hospital stay compared between groups. |
| Platelet and neutrophil engraftment | Aproximately14 days post-transplant | 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. |
| Fried Frailty Index score | Day +30, and Day +100 post-transplant | Fried Frailty Index score ranges from 0 to 5, where higher scores indicate greater frailty (worse functional status). |
| Activities of Daily Living (ADL) | Day +30, and Day +100 post-transplant | 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). |
| Instrumental Activities of Daily Living (IADL) | Day +30, and Day +100 post-transplant | 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). |
| Karnofsky Performance Scale | Day +30, and Day +100 post-transplant | Karnofsky Performance Scale ranges from 0 to 100, where higher scores indicate better functional status. |
Countries
United States
Contacts
CONTACTKrishna vamsi Gottipati, MS
CONTACTIIT Office Clinical Trails Office
PRINCIPAL_INVESTIGATORMichael Haddadin, MD
University of Nebraska
Outcome results
None listed