Clinical trial NCT06559709: A Plant-Based Whole-Foods Meal Delivery Service for Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplant
Official title: Implementing a Plant-Based Whole-Foods Meal Delivery Service for Patients Undergoing Autologous Hematopoietic Cell Transplantation for Multiple Myeloma: A Pilot Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Myeloma
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: Swim Across America
First posted: 2024-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: Enrollment rate
timeFrame: Up to 1 year
measure: Collection rate
timeFrame: Up to 1 month post transplant
measure: Tolerability of the delivered diet: Patient opinion
timeFrame: Up to 1 month post transplant
measure: Tolerability of the delivered diet: Proportion of meals consumed
timeFrame: Up to 1 month post transplant
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Kate Markey
role: PRINCIPAL_INVESTIGATOR
References: