Malignant Neoplasm
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBoost Plus
Receive nutritional supplementation twice daily to provide 28g of protein
DIETARY_SUPPLEMENTPro-Stat 101
Receive nutritional supplementation twice daily to provide 30g of protein
DIETARY_SUPPLEMENTMilkshake
Receive alternate nutritional supplementation once daily to provide 28g protein
OTHERdaily food diaries
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
Sponsors
National Cancer Institute (NCI)
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA) | 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
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay, defined by time of admission through discharge | Up to time of hospital discharge, up to 1 year | Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients. |
| Change in serum albumin | Baseline, up to time of hospital discharge, up to 1 year | Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients. |
| Change in serum 25-hydroxy vitamin D | Baseline, up to time of hospital discharge, up to 1 year | Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients. |
| Degree of mucositis | Week 2, Week 3, Week 4, up to time of hospital discharge, up to 52 weeks | Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients. |
| 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 | Longitudinal analysis of these ancillary variables will be performed to see the benefit of oral supplementation in the HSCT patients. |
Countries
United States
Outcome results
None listed