The Effect of Oral Supplementation and Improved Nutritional Status on Hematopoietic Stem Cell Transplant Patients
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Malignant Neoplasm
- Sponsor
- Case Comprehensive Cancer Center
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA)
- Status
- Terminated
- Last Updated
- 7 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA)
Time Frame: Baseline to time of hospital discharge, up to 1 year
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.
Secondary Outcomes
- Degree of mucositis(Week 2, Week 3, Week 4, up to time of hospital discharge, up to 52 weeks)
- Length of hospital stay, defined by time of admission through discharge(Up to time of hospital discharge, up to 1 year)
- Change in serum albumin(Baseline, up to time of hospital discharge, up to 1 year)
- Change in serum 25-hydroxy vitamin D(Baseline, up to time of hospital discharge, up to 1 year)
- Time to engraftment, defined by the first of three consecutive days that the absolute neutrophil count is greater than 500(Up to time of hospital discharge, up to 1 year)