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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02590107
Other study ID # CASE6Z14
Secondary ID NCI-2015-00477CA
Status Terminated
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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