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
  Purpose

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.


Condition Intervention Phase
Hodgkin's Lymphoma
Multiple Myeloma
Non-Hodgkin's Lymphoma
Dietary Supplement: Nestle Impact Advanced Recovery
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant

Resource links provided by NLM:


Further study details as provided by University of Kentucky:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: September 2012
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Nestle Impact Advanced Recovery

Nestle Impact Advanced Recovery

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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01699581

Contacts
Contact: John W Hayslip, MD 859-323-8718 jhays2@uky.edu
Contact: Patricia Levitt 859-257-4465 pklevi2@uky.edu

Locations
United States, Kentucky
University of Kentucky, Markey Cancer Center Recruiting
Lexington, Kentucky, United States, 40536
Principal Investigator: John W Hayslip, MD         
Sponsors and Collaborators
John Haslip
Investigators
Principal Investigator: John W Hayslip, MD Lucille P. Markey Cancer Center at University of Kentucky
  More Information

No publications provided

Responsible Party: John Haslip, Director, Clinical Research and Data Management Shared Resource Facility, University of Kentucky
ClinicalTrials.gov Identifier: NCT01699581     History of Changes
Other Study ID Numbers: 11-HEM-03-MCC
Study First Received: September 27, 2012
Last Updated: November 14, 2013
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Keywords provided by University of Kentucky:
Hodgkin's Lymphoma
Multiple Myeloma
Non-Hodgkin's Lymphoma

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma
Lymphoma, Non-Hodgkin
Multiple Myeloma
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders

ClinicalTrials.gov processed this record on April 17, 2014