Study Stopped
Research cancelled following interim analysis
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
1 other identifier
interventional
35
1 country
1
Brief Summary
Nestle Impact has shown efficacy in multiple surgical trials in relation to improving hospital length of stay and infection rate. 1 dose of Nestle Impact Advanced Recovery will be taken orally three times a day beginning on the morning following stem cell transplant and will continue until the day of hospital discharge.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Sep 2012
Typical duration for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
September 27, 2012
CompletedFirst Posted
Study publicly available on registry
October 3, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedOctober 18, 2016
October 1, 2016
1.7 years
September 27, 2012
October 17, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Hospital length of stay
Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
Days to engraftment
Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
Study Arms (1)
Nestle Impact Advanced Recovery
EXPERIMENTALNestle Impact Advanced Recovery 1 dose of Nestle Impact Advanced Recovery orally three times a day
Interventions
dose of Nestle Impact Advanced Recovery orally three times a day beginning on the morning following stem cell transplant and continued until the day of hospital discharge.
Eligibility Criteria
You may qualify if:
- Patients receiving an autologous stem cell transplant using the preparative regimens of BEAM (Carmustine, Etoposide, Cytarabine, Melphalan), Melphalan 140mg/m2, or Melphalan 200mg/m2
- Any prior diet or supplement will be allowed.
- Age \>18 years.
- Ability to understand and the willingness to sign a written informed consent document.
You may not qualify if:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nestle Impact including fish oil.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Greg Monohanlead
Study Sites (1)
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, 40536, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Greg Monohan, MD
Lucille P. Markey Cancer Center at University of Kentucky
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 27, 2012
First Posted
October 3, 2012
Study Start
September 1, 2012
Primary Completion
June 1, 2014
Study Completion
October 1, 2015
Last Updated
October 18, 2016
Record last verified: 2016-10