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NCT01699581 Clinical Trial

Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant

Multiple Myeloma Clinical Trial

Official title:
Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01699581
Other study ID # 11-HEM-03-MCC
Secondary ID
Status Terminated
Phase Phase 2
First received September 27, 2012
Last updated October 17, 2016
Start date September 2012
Est. completion date October 2015

Study information
Verified date October 2016
Source University of Kentucky
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Terminated
Enrollment 35
Est. completion date October 2015
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States University of Kentucky, Markey Cancer Center Lexington Kentucky

Sponsors (1)
Lead Sponsor Collaborator
Greg Monohan

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Hospital length of stay Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge No
Primary Days to engraftment Particpants will be followed for 14 days, the average length of time from stem cell infusion until dischcarge No
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