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Clinical Trials/NCT03449927
NCT03449927
Completed
Phase 1

A Pilot Study of Implementation of a Nutritional Tool During Melphalan Autologous Transplant to Improve Caloric and Protein Intake

Washington University School of Medicine1 site in 1 country20 target enrollmentJanuary 1, 2018

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Melphalan Autologous Transplant
Sponsor
Washington University School of Medicine
Enrollment
20
Locations
1
Primary Endpoint
Pre and post intervention mean total caloric intake
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this pilot before and after interventional study is to determine if early intervention and provision of menus regarding appropriate diet choices for melphalan autologous transplant patients experiencing nausea and diarrhea will improve nutrition status and overall calorie and protein intake throughout the transplant process.

Registry
clinicaltrials.gov
Start Date
January 1, 2018
End Date
February 27, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients undergoing melphalan autologous transplants will be included in this study
  • All patients that will be included in this pilot before and after interventional study will be inpatient on floors 5900, 6900 or 8900 of Barnes-Jewish Hospital
  • Per hospital protocol, all patients who will receive a melphalan autologous transplant will be admitted and remain inpatient for the duration of the transplant process. There will be no exclusion for dietary restrictions or food allergies as the foodservice provided to patients is room service, all food allergies are noted and suitable alternatives are provided as a standard of service.
  • Once a patient has been determined to meet criteria for the study, they will be approached by a member of the research team between day -2 and day 0 of transplant for consent. Patients must consent for the study by day +1 of transplant to be enrolled.

Exclusion Criteria

  • Patients \<18 years of age
  • Pregnant women
  • Prisoners
  • Patient unable to provide informed consent.

Outcomes

Primary Outcomes

Pre and post intervention mean total caloric intake

Time Frame: Through count recovery (10 days)

Mean total protein intake

Time Frame: Through count recovery (10 days)

Secondary Outcomes

  • Mean daily caloric intake(Through count recovery (10 days))
  • Mean daily protein intake(Through count recovery (10 days))

Study Sites (1)

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