Early Oral Supplementation in Improving Nutritional Status in Patients Undergoing Hematopoietic Stem Cell Transplant

Study Overview
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Brief Summary
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This clinical trial studies the use of early oral supplementation in improving nutritional status in participants undergoing hematopoietic stem cell transplant. Impaired nutritional status in participants undergoing hematopoietic stem cell transplant has been linked to decreased outcomes such as increased length of hospital stay and increased time to engraftment (an important milestone in transplant recovery). Early oral supplementation may increase nutritional status and help to promote a positive outcome in participants undergoing transplant.

Detailed Description
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PRIMARY OBJECTIVES: I. To determine if early oral supplementation improves nutritional status, decreases length of hospital stay, and shortens time to engraftment of hematopoietic stem cell transplant (HSCT) participants. SECONDARY OBJECTIVES: I. Serum albumin, serum 25-hydroxy vitamin D, and the degree of mucositis, as scored by the National Cancer Institute's Common Toxicity Criteria (NCI-CTC), a validated and widely accepted scale used for rating mucositis. The purpose of our secondary aims is to observe a potential correlation between the retrospective and prospective groups, as well as assess the need for future research based on these correlations. OUTLINE: Participants receive Boost Plus orally (PO) twice daily (BID) or Pro-Stat 101 PO BID beginning one week before scheduled HSCT and continuing until hospital discharge. If participants do not tolerate the Boost Plus or Pro-Stat, they receive a milkshake PO once daily (QD) as an alternative.

Official Title
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The Effect of Oral Supplementation and Improved Nutritional Status on Hematopoietic Stem Cell Transplant Patients

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Dietary Supplement: Boost Plus
* Dietary Supplement: Pro-Stat 101
* Dietary Supplement: Milkshake
* Other: daily food diaries


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing an autologous or reduced intensity conditioning (RIC) allogeneic HSCT A serum albumin greater than or equal to 2.5 g/dL Able to understand and sign consent Exclusion Criteria: Patients who have malabsorption problems, such as ulcerative colitis, irritable bowel syndrome, Crohn's disease, bowel surgery such as gastric bypass, and celiac disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive care (Boost Plus, Pro-Stat 101)<br>Participants receive Boost Plus PO BID or Pro-Stat 101 PO BID beginning one week before scheduled HSCT and continuing until hospital discharge. If participants do not tolerate the Boost Plus or Pro-Stat, they receive a milkshake PO QD as an alternative. | Dietary Supplement: Boost Plus<br>* Receive nutritional supplementation twice daily to provide 28g of protein<br>* Other names: Supplementation;Dietary Supplement: Pro-Stat 101<br>* Receive nutritional supplementation twice daily to provide 30g of protein<br>* Other names: Supplementation;Dietary Supplement: Milkshake<br>* Receive alternate nutritional supplementation once daily to provide 28g protein<br>* Other names: Supplementation;Other: daily food diaries<br>* Participants will be given a food intake form, clipboard, and pen to record specific foods, as well as amounts of foods that are consumed from outside sources. In addition, the specific food items that each participant consumes will be recorded by the participant on his or her meal tickets which are included with each meal tray<br>* Other names: food intake form;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA) | To test the improvement of nutritional status over a period of time, a linear mixed model will be fit and the PG-SGA trend will be tested. | Baseline to time of hospital discharge, up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay, defined by time of admission through discharge | Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients. | Up to time of hospital discharge, up to 1 year | 
| Change in serum albumin | Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients. | Baseline, up to time of hospital discharge, up to 1 year | 
| Change in serum 25-hydroxy vitamin D | Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients. | Baseline, up to time of hospital discharge, up to 1 year | 
| Degree of mucositis | Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients. | Week 2, Week 3, Week 4, up to time of hospital discharge, up to 52 weeks | 
| Time to engraftment, defined by the first of three consecutive days that the absolute neutrophil count is greater than 500 | Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients. | Up to time of hospital discharge, up to 1 year |