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Trial Title:
A Plant-Based Whole-Foods Meal Delivery Service for Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplant
NCT ID:
NCT06559709
Condition:
Multiple Myeloma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Biospecimen Collection
Description:
Undergo blood and stool sample collection
Arm group label:
Supportive care (meal delivery service)
Other name:
Biological Sample Collection
Other name:
Biospecimen Collected
Other name:
Specimen Collection
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Receive 3 meals per day and snacks
Arm group label:
Supportive care (meal delivery service)
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Other
Intervention name:
Dietary Intervention
Description:
Meet with dietitian
Arm group label:
Supportive care (meal delivery service)
Other name:
Dietary Modification
Other name:
intervention, dietary
Other name:
Nutrition Intervention
Other name:
Nutrition Interventions
Other name:
Nutritional Interventions
Intervention type:
Other
Intervention name:
Medical Chart Review
Description:
Ancillary studies
Arm group label:
Supportive care (meal delivery service)
Other name:
Chart Review
Intervention type:
Other
Intervention name:
Questionnaire Administration
Description:
Ancillary studies
Arm group label:
Supportive care (meal delivery service)
Summary:
This clinical trial evaluates the impact of a plant-based whole-foods delivery service on
the microbiome in patients with multiple myeloma undergoing an autologous hematopoietic
cell transplant. An autologous hematopoietic cell transplant is a procedure in which
blood-forming stem cells (cells from which all blood cells develop) are removed, stored,
and later given back to the same person. Loss of microbial diversity within the
intestinal tract has been associated with poor outcomes for patients receiving autologous
stem cell transplantation. A plant-based whole meal delivery service may increase the
intake of foods high in fiber and nutrients therefore improve microbial health during the
peri-transplant period. In this pilot study, study investigators will explore the
feasibility of this approach.
Detailed description:
OUTLINE:
Patients receive 3 meals per day and snacks delivered twice weekly and meet with
dietitian once weekly on days -7 to 28. Patients undergo blood and stool sample
collection on study.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Able to provide written informed consent prior to initiation of any study procedures
- Planned first autologous stem cell transplantation for multiple myeloma
- Planned outpatient treatment for the duration of transplantation (if admitted, the
investigators will request that caregivers bring the meals/snacks to the hospital as
they might with other food prepared at home)
- Access to a refrigerator
- Ability to reheat foods
- Able to consume an oral diet at enrollment
- Able to communicate clearly regarding aspects of the study: e.g. Give feedback on
logistics and meals, in order to maximize the operational data the investigators can
gather in this pilot study
- At least 18 years of age
Exclusion Criteria:
- Major psychiatric diagnosis that impairs cognitive functioning or is not controlled
at the time of the approach, as judged by the patient's medical team
- Planned inpatient transplantation
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Fred Hutch/University of Washington Cancer Consortium
Address:
City:
Seattle
Zip:
98109
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kate Markey
Phone:
206-667-7195
Email:
kmarkey@fredhutch.org
Investigator:
Last name:
Kate Markey
Email:
Principal Investigator
Start date:
October 14, 2024
Completion date:
June 25, 2025
Lead sponsor:
Agency:
Fred Hutchinson Cancer Center
Agency class:
Other
Collaborator:
Agency:
Swim Across America
Agency class:
Other
Source:
Fred Hutchinson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06559709
