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Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant

This study has suspended participant recruitment.
(Interim analysis)
Sponsor:
Information provided by (Responsible Party):
Greg Monohan, University of Kentucky
ClinicalTrials.gov Identifier:
NCT01699581
First received: September 27, 2012
Last updated: May 28, 2014
Last verified: May 2014

September 27, 2012
May 28, 2014
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.
 
Suspended
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 information is only displayed when the study is recruiting subjects
United States
 
NCT01699581
11-HEM-03-MCC
Yes
Greg Monohan, University of Kentucky
Greg Monohan
Not Provided
Principal Investigator: Greg Monohan, MD Lucille P. Markey Cancer Center at University of Kentucky
University of Kentucky
May 2014

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