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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

Tracking Information
First Submitted Date  ICMJE October 27, 2015
First Posted Date  ICMJE October 28, 2015
Last Update Posted Date May 15, 2018
Actual Study Start Date  ICMJE April 1, 2016
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02590107 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2015)
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Oral Supplementation in Improving Nutritional Status in Patients Undergoing Hematopoietic Stem Cell Transplant
Official Title  ICMJE The Effect of Oral Supplementation and Improved Nutritional Status on Hematopoietic Stem Cell Transplant Patients
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 Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Malignant Neoplasm
Intervention  ICMJE
  • 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
Study Arms 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: May 9, 2018)
5
Original Estimated Enrollment  ICMJE
 (submitted: October 27, 2015)
98
Actual Study Completion Date March 1, 2018
Actual Primary Completion Date March 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02590107
Other Study ID Numbers  ICMJE CASE6Z14
NCI-2015-00477 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE6Z14 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Case Comprehensive Cancer Center
Study Sponsor  ICMJE Case Comprehensive Cancer Center
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Director: Autumn Diligente, MS, RDN, LD Case Comprehensive Cancer Center
Principal Investigator: Stephanie Logosh, MS, RDN, LD Case Comprehensive Cancer Center
PRS Account Case Comprehensive Cancer Center
Verification Date May 2018

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