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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02590107
• Other study ID #: CASE6Z14
• Secondary ID: NCI-2015-00477CA
• Status: Terminated
• Phase: N/A
• Start date: April 1, 2016
• Est. completion date: March 1, 2018

Study information

• Verified date: May 2018
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: March 1, 2018
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Neoplasm
• Neoplasms

Intervention

Dietary Supplement:
• Boost Plus
Receive nutritional supplementation twice daily to provide 28g of protein
• Pro-Stat 101
Receive nutritional supplementation twice daily to provide 30g of protein
• 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

Locations

Country	Name	City	State
United States	Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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