Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant
This study is currently recruiting participants.
Verified April 2013 by University of Kentucky
Sponsor:
University of Kentucky
Information provided by (Responsible Party):
University of Kentucky
ClinicalTrials.gov Identifier:
NCT01699581
First received: September 27, 2012
Last updated: April 5, 2013
Last verified: April 2013
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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
University of Kentucky
Investigators
| Principal Investigator: | John W Hayslip, MD | Lucille P. Markey Cancer Center at University of Kentucky |
More Information
No publications provided
| Responsible Party: | 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: | April 5, 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 May 23, 2013