Back to resultsAssessment of Impact Nutritional Program During Autologous Stem Cell Transplant
Primary Purpose
Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Nestle Impact Advanced Recovery
Sponsored by
About this trial
This is an interventional treatment trial for Hodgkin's Lymphoma focused on measuring Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nestle Impact including fish oil.
Sites / Locations
- University of Kentucky, Markey Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Nestle Impact Advanced Recovery
Arm Description
Nestle Impact Advanced Recovery 1 dose of Nestle Impact Advanced Recovery orally three times a day
Outcomes
Primary Outcome Measures
Hospital length of stay
Days to engraftment
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01699581
Brief Title
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
Official Title
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Research cancelled following interim analysis
Study Start Date
September 2012 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Greg Monohan
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma
Keywords
Hodgkin's Lymphoma, Multiple Myeloma, Non-Hodgkin's Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Nestle Impact Advanced Recovery
Arm Type
Experimental
Arm Description
Nestle Impact Advanced Recovery
1 dose of Nestle Impact Advanced Recovery orally three times a day
Intervention Type
Dietary Supplement
Intervention Name(s)
Nestle Impact Advanced Recovery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hospital length of stay
Time Frame
Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
Title
Days to engraftment
Time Frame
Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
History of allergic reactions attributed to compounds of similar chemical or biologic composition to Nestle Impact including fish oil.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Greg Monohan, MD
Organizational Affiliation
Lucille P. Markey Cancer Center at University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Kentucky, Markey Cancer Center
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
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