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

Not Applicable

Terminated

• Conditions: Malignant Neoplasm
• Interventions: Dietary Supplement: Boost Plus; Dietary Supplement: Pro-Stat 101; Dietary Supplement: Milkshake; Other: daily food diaries

• Registration Number: NCT02590107
• Lead Sponsor: Case Comprehensive Cancer Center

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.

Study Timeline

• Study First Submitted: 2015-10-27
• Study First Submitted QC: 2015-10-27
• Study First Posted: 2015-10-28
• Study Start: 2016-04-01
• Primary Completion: 2018-03-01
• Study Completion: 2018-03-01
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-09
• Last Update Posted: 2018-05-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (Boost Plus, Pro-Stat 101)	Boost Plus	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.
Supportive care (Boost Plus, Pro-Stat 101)	Milkshake	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.
Supportive care (Boost Plus, Pro-Stat 101)	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.
Supportive care (Boost Plus, Pro-Stat 101)	daily food diaries	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (1)

Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States