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Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant

This study has been terminated.
(Research cancelled following interim analysis)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01699581
First Posted: October 3, 2012
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Greg Monohan, University of Kentucky
  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: Intervention Model: Single Group Assignment
Masking: None (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 Greg Monohan, 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 ]
  • Days to engraftment [ Time Frame: Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge ]

Enrollment: 35
Study Start Date: September 2012
Study Completion Date: October 2015
Primary Completion Date: June 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01699581


Locations
United States, Kentucky
University of Kentucky, Markey Cancer Center
Lexington, Kentucky, United States, 40536
Sponsors and Collaborators
Greg Monohan
Investigators
Principal Investigator: Greg Monohan, MD Lucille P. Markey Cancer Center at University of Kentucky
  More Information

Responsible Party: Greg Monohan, Principal Investigator, University of Kentucky
ClinicalTrials.gov Identifier: NCT01699581     History of Changes
Other Study ID Numbers: 11-HEM-03-MCC
First Submitted: September 27, 2012
First Posted: October 3, 2012
Last Update Posted: October 18, 2016
Last Verified: October 2016

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

Additional relevant MeSH terms:
Lymphoma
Multiple Myeloma
Neoplasms, Plasma Cell
Lymphoma, Non-Hodgkin
Hodgkin Disease
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