ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Malignant Neoplasm Dietary Supplement: Boost Plus Dietary Supplement: Pro-Stat 101 Dietary Supplement: Milkshake Other: daily food diaries Not Applicable

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  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Oral Supplementation and Improved Nutritional Status on Hematopoietic Stem Cell Transplant Patients
Actual Study Start Date : April 1, 2016
Actual Primary Completion Date : March 1, 2018
Actual Study Completion Date : March 1, 2018

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 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02590107


Locations
United States, Ohio
Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44106-5065
Sponsors and Collaborators
Case Comprehensive Cancer Center
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

Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT02590107     History of Changes
Other Study ID Numbers: CASE6Z14
NCI-2015-00477 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
CASE6Z14 ( Other Identifier: Case Comprehensive Cancer Center )
P30CA043703 ( U.S. NIH Grant/Contract )
First Posted: October 28, 2015    Key Record Dates
Last Update Posted: May 15, 2018
Last Verified: May 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Neoplasms