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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03449927
Enrollment
20
Registered
2018-02-28
Start date
2018-01-01
Completion date
2018-02-27
Last updated
2019-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melphalan Autologous Transplant

Keywords

Nutrition Tool, Melphalan Autologous Transplant

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.

Interventions

OTHERSpecialized menu

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

OTHERStandard of care menu

-Standard registered dietitian support

OTHERSelf report dietary intake worksheet

-Self report nausea and diarrhea

OTHERPost study questionnaire

-Completed upon count recovery and prior to discharge

Sponsors

Barnes-Jewish Hospital
CollaboratorOTHER
Washington University School of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
Pre and post intervention mean total caloric intakeThrough count recovery (10 days)
Mean total protein intakeThrough count recovery (10 days)

Secondary

MeasureTime frame
Mean daily caloric intakeThrough count recovery (10 days)
Mean daily protein intakeThrough count recovery (10 days)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026