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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
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Greg Monohan, Principal Investigator, 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: May 28, 2014
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
Blood Protein Disorders
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Paraproteinemias
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014