Assessment of Impact Nutritional Program During Autologous Stem Cell Transplant

NCT ID: NCT01699581

Last Updated: 2016-10-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2015-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hodgkin's Lymphoma Multiple Myeloma Non-Hodgkin's Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nestle Impact Advanced Recovery

Nestle Impact Advanced Recovery

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

Group Type EXPERIMENTAL

Nestle Impact Advanced Recovery

Intervention Type DIETARY_SUPPLEMENT

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.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Greg Monohan

OTHER

Sponsor Role lead

Responsible Party

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Greg Monohan

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Greg Monohan, MD

Role: PRINCIPAL_INVESTIGATOR

Lucille P. Markey Cancer Center at University of Kentucky

Locations

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University of Kentucky, Markey Cancer Center

Lexington, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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11-HEM-03-MCC

Identifier Type: -

Identifier Source: org_study_id

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