NCT02590107

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 27, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 2015

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2016

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2018

Completed
Last Updated

May 15, 2018

Status Verified

May 1, 2018

Enrollment Period

1.9 years

First QC Date

October 27, 2015

Last Update Submit

May 9, 2018

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Length of hospital stay, defined by time of admission through discharge

    Up to time of hospital discharge, up to 1 year

  • Change in serum albumin

    Baseline, up to time of hospital discharge, up to 1 year

  • Change in serum 25-hydroxy vitamin D

    Baseline, up to time of hospital discharge, up to 1 year

  • Degree of mucositis

    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

    Up to time of hospital discharge, up to 1 year

Study Arms (1)

Supportive care (Boost Plus, Pro-Stat 101)

EXPERIMENTAL

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 PlusDietary Supplement: Pro-Stat 101Dietary Supplement: MilkshakeOther: daily food diaries

Interventions

Boost PlusDIETARY_SUPPLEMENT

Receive nutritional supplementation twice daily to provide 28g of protein

Also known as: Supplementation
Supportive care (Boost Plus, Pro-Stat 101)
Pro-Stat 101DIETARY_SUPPLEMENT

Receive nutritional supplementation twice daily to provide 30g of protein

Also known as: Supplementation
Supportive care (Boost Plus, Pro-Stat 101)
MilkshakeDIETARY_SUPPLEMENT

Receive alternate nutritional supplementation once daily to provide 28g protein

Also known as: Supplementation
Supportive care (Boost Plus, Pro-Stat 101)
daily food diariesOTHER

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

Also known as: food diary, food intake form
Supportive care (Boost Plus, Pro-Stat 101)

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients who have malabsorption problems, such as ulcerative colitis, irritable bowel syndrome, Crohn's disease, bowel surgery such as gastric bypass, and celiac disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Case Comprehensive Cancer Center

Cleveland, Ohio, 44106-5065, United States

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Dietary SupplementsDiet Records

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and BeveragesRecordsOrganization and AdministrationHealth Services Administration

Study Officials

  • Autumn Diligente, MS, RDN, LD

    Case Comprehensive Cancer Center

    STUDY DIRECTOR

  • Stephanie Logosh, MS, RDN, LD

    Case Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 27, 2015

First Posted

October 28, 2015

Study Start

April 1, 2016

Primary Completion

March 1, 2018

Study Completion

March 1, 2018

Last Updated

May 15, 2018

Record last verified: 2018-05

Locations

US(1)