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OpenTrials
Completed

NCT Number: NCT03449927

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

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.

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Key information

Conditions

Melphalan Autologous Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Specialized menu

Other

-Specialized menu that will guide participant food choices if the participant experiences nausea or diarrhea

Standard of care menu

Other

-Standard registered dietitian support

Self report dietary intake worksheet

Other

-Self report nausea and diarrhea

Post study questionnaire

Other

-Completed upon count recovery and prior to discharge

Primary outcomes

  1. Pre and post intervention mean total caloric intake

    Time frame: Through count recovery (10 days)

  2. Mean total protein intake

    Time frame: Through count recovery (10 days)

Secondary outcomes

  1. Mean daily caloric intake

    Time frame: Through count recovery (10 days)

  2. Mean daily protein intake

    Time frame: Through count recovery (10 days)

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

  • Barnes-Jewish Hospital

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 28, 2018
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.