A Plant-Based Whole-Foods Meal Delivery Service for Patients With Multiple Myeloma Undergoing Autologous Hematopoietic Cell Transplant

Not Applicable

Recruiting

• Conditions: Multiple Myeloma
• Interventions: Procedure: Biospecimen Collection; Other: Dietary Intervention; Other: Medical Chart Review; Other: Questionnaire Administration

• Registration Number: NCT06559709
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Study Timeline

• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-08-16
• Study First Posted: 2024-08-19
• Study Start: 2024-10-14
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2025-06-25
• Study Completion: 2025-06-25

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Supportive care (meal delivery service)	Biospecimen Collection	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.
Supportive care (meal delivery service)	Dietary Intervention	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.
Supportive care (meal delivery service)	Questionnaire Administration	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.
Supportive care (meal delivery service)	Medical Chart Review	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.

Primary Outcome Measures

Name	Time	Method
Tolerability of the delivered diet: Patient opinion	Up to 1 month post transplant	Patient opinion of the delivered meals will be assessed using qualitative end-study surveys.
Enrollment rate	Up to 1 year	The proportion of eligible patients who consent to enroll in the study will be computed based on the number approached and estimated with 95% confidence intervals. Reasons for non-participation will be summarized.
Collection rate	Up to 1 month post transplant	Collection rate will be the percentage of stool samples, blood samples and surveys collected.
Tolerability of the delivered diet: Proportion of meals consumed	Up to 1 month post transplant	Patient acceptability of the delivered meals will be assessed using proportions of the delivered meals consumed based on multi-day food diaries and 24-hour recall assessments.

Trial Locations

Locations (1)

Fred Hutch/University of Washington Cancer Consortium; 🇺🇸 Seattle, Washington, United States