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

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ClinicalTrials.gov Identifier: NCT02590107
Recruitment Status : Terminated (Slow Accrual)
First Posted : October 28, 2015
Last Update Posted : May 15, 2018
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

October 27, 2015
October 28, 2015
May 15, 2018
April 1, 2016
March 1, 2018   (Final data collection date for primary outcome measure)
Change in nutritional status determined by the Patient-Generated Subjective Global Assessment (PG-SGA) [ Time Frame: 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.
Same as current
Complete list of historical versions of study NCT02590107 on ClinicalTrials.gov Archive Site
  • Length of hospital stay, defined by time of admission through discharge [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
  • Degree of mucositis [ Time Frame: 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.
  • Time to engraftment, defined by the first of three consecutive days that the absolute neutrophil count is greater than 500 [ Time Frame: 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.
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Not Applicable
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Malignant Neoplasm
  • Dietary Supplement: Boost Plus
    Receive nutritional supplementation twice daily to provide 28g of protein
    Other Name: Supplementation
  • Dietary Supplement: Pro-Stat 101
    Receive nutritional supplementation twice daily to provide 30g of protein
    Other Name: Supplementation
  • Dietary Supplement: Milkshake
    Receive alternate nutritional supplementation once daily to provide 28g protein
    Other Name: 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
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.
Interventions:
  • Dietary Supplement: Boost Plus
  • Dietary Supplement: Pro-Stat 101
  • Dietary Supplement: Milkshake
  • Other: daily food diaries
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
98
March 1, 2018
March 1, 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02590107
CASE6Z14
NCI-2015-00477 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE6Z14 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
Yes
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Director: Autumn Diligente, MS, RDN, LD Case Comprehensive Cancer Center
Principal Investigator: Stephanie Logosh, MS, RDN, LD Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP