CClinicalTrials.gg
CompletedNCT03449927Updated Mar 13, 2019

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

A Phase 1 interventional study of Specialized menu and Standard of care menu in Melphalan Autologous Transplant, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-03-13.

Sponsored by Washington University School of Medicine · Phase 1, Interventional, and Supportive care

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Melphalan Autologous Transplant

Keywords

  • Nutrition Tool
  • Melphalan Autologous Transplant
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Patients \<18 years of age
  • Pregnant women
  • Prisoners
  • Patient unable to provide informed consent.
04

Study design

Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Active comparator
    Control Arm: Regular menu

    * Calorie count initiated on day +1 of transplant and ending upon count recovery * Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000) * Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea * Interventions provided for control group: standard of care, verbal or printed handouts, standard educations created by Barnes Jewish Hospital (BJH) oncology dietitians

    Other: Standard of care menu · Other: Self report dietary intake worksheet · Other: Post study questionnaire

  • Experimental
    Intervention Arm: Specialized Menu

    * Calorie count and tool provided on day +1 and ending upon count recovery * Symptom worksheet initiated on day +1 of transplant and ending upon count recovery (absolute neutrophil count of 1000) * Goals to monitor: calorie and protein intake, self-reported diarrhea and nausea * Interventions provided for intervention group: standard of care provided by BJH oncology dietitians, tools including nausea and diarrhea menus and follow up by registered dietitian (RD) to provide additional counseling on menus as symptoms arise

    Other: Specialized menu · Other: Self report dietary intake worksheet · Other: Post study questionnaire

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

05

What researchers measure

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)

06

Study locations

1 site
  • Washington University School of Medicine
    Saint Louis, Missouri 63110, United States
07

References and documents

08

Registry details

Key details

Study ID
NCT03449927
Lead sponsor
Washington University School of Medicine
Collaborators
Barnes-Jewish Hospital
Responsible party
Sponsor
First posted
Feb 28, 2018
Start date
Jan 1, 2018
Primary completion
Feb 27, 2018
Completion
Feb 27, 2018
Last update
Mar 13, 2019

Study contacts

Kathleen Stockmann, MS, RD, LD
principal investigator · Washington University School of Medicine
Meaghan Ryan, MSN, FNP-BC
principal investigator · Washington University School of Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
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