Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant

This study is currently recruiting participants.
Verified November 2013 by University of Kentucky
Sponsor:
Information provided by (Responsible Party):
John Haslip, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01699581
First received: September 27, 2012
Last updated: November 14, 2013
Last verified: November 2013

September 27, 2012
November 14, 2013
September 2012
October 2014   (final data collection date for primary outcome measure)
  • Hospital length of stay [ Time Frame: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge ] [ Designated as safety issue: No ]
  • Days to engraftment [ Time Frame: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01699581 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant

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.

Not Provided
Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hodgkin's Lymphoma
  • Multiple Myeloma
  • Non-Hodgkin's Lymphoma
Dietary Supplement: Nestle Impact Advanced Recovery
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.
Experimental: Nestle Impact Advanced Recovery

Nestle Impact Advanced Recovery

1 dose of Nestle Impact Advanced Recovery orally three times a day

Intervention: Dietary Supplement: Nestle Impact Advanced Recovery
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
70
October 2015
October 2014   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: John W Hayslip, MD 859-323-8718 jhays2@uky.edu
Contact: Patricia Levitt 859-257-4465 pklevi2@uky.edu
United States
 
NCT01699581
11-HEM-03-MCC
Yes
John Haslip, University of Kentucky
John Haslip
Not Provided
Principal Investigator: John W Hayslip, MD Lucille P. Markey Cancer Center at University of Kentucky
University of Kentucky
November 2013

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