NCT02590107

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

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

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Case Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Neoplasm

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Boost Plus	Receive nutritional supplementation twice daily to provide 28g of protein
DIETARY_SUPPLEMENT	Pro-Stat 101	Receive nutritional supplementation twice daily to provide 30g of protein
DIETARY_SUPPLEMENT	Milkshake	Receive alternate nutritional supplementation once daily to provide 28g protein
OTHER	daily 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

Timeline

• Start date: 2016-04-01
• Primary completion: 2018-03-01
• Completion: 2018-03-01
• First posted: 2015-10-28
• Last updated: 2018-05-15

Locations

1 site across 1 country: United States