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

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.

Study Overview

• Status: Terminated
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Dietary supplement: Boost Plus; Dietary supplement: Pro-Stat 101; Dietary supplement: Milkshake; Other: daily food diaries

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.

• Study Type: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106-5065
      • Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Supportive care (Boost Plus, Pro-Stat 101); Participants receive Boost Plus PO 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 QD as an alternative.

Dietary supplement: Boost Plus; Receive nutritional supplementation twice daily to provide 28g of protein; Other Names: Supplementation; Dietary supplement: Pro-Stat 101; Receive nutritional supplementation twice daily to provide 30g of protein; Other Names: Supplementation; Dietary supplement: Milkshake; Receive alternate nutritional supplementation once daily to provide 28g protein; Other Names: Supplementation; 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; Other Names: food diary; food intake form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Director: Autumn Diligente, MS, RDN, LD, Case Comprehensive Cancer Center; Principal Investigator: Stephanie Logosh, MS, RDN, LD, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: October 27, 2015
• First Submitted That Met QC Criteria: October 27, 2015
• First Posted (Estimate): October 28, 2015

Study Record Updates

• Last Update Posted (Actual): May 15, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CASE6Z14 (Other Identifier: Case Comprehensive Cancer Center); P30CA043703 (U.S. NIH Grant/Contract); NCI-2015-00477 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No