This trial investigates the effect of fermented milk supplementation on symptoms of disease and treatment in patients with multiple myeloma. Patients with multiple myeloma may experience symptoms related to the disease and/or treatment that affect quality of life. Supplementing usual diet with a probiotic fermented milk product called kefir may contribute to reducing disease and treatment-related side effects through changing the intestinal bacteria community structure and related metabolism.
PRIMARY OBJECTIVE: I. Determine the effect of a 3-month randomized dietary intervention with a probiotic kefir beverage in multiple myeloma (MM) patients on biomarkers of metabolism, and patient-reported pain and fatigue, gut health, and quality of life (QoL). SECONDARY OBJECTIVE: I. Determine the effect of kefir supplementation on gut microbial phylotype and predicted bacterial metabolic function, and assess associations with biomarkers of metabolism, and patient-reported pain and fatigue, gut health, and QoL. EXPLORATORY OBJECTIVE: I. Feasibility of a probiotic lifestyle intervention in MM patients. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients consume commercial kefir beverage daily for 3 months. ARM II: Patients maintain usual diet for 3 months. After completion of study, patients are followed up at 30 days or until resolution of any study related toxicity.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
13
Maintain usual diet
Consume commercial kefir beverage
Ancillary studies
Roswell Park Cancer Institute
Buffalo, New York, United States
Changes in levels of parathyroid hormone (PTH)
Collect Changes in values of PTH from baseline to week 12in patients who added kefir to their diet
Time frame: Week 12
Change in quality of life
Will be assessed by European Organization for Research and Treatment of Cancer (EORTC)-Quality of Life-Core 30 and EORTC Myeloma module. Will compare the changes in outcomes pre- to post-intervention between groups using an ANCOVA model
Time frame: Up to 30 days post-intervention
Overall Gut microbial community structure
Will evaluate changes in microbial community structure, measured as a beta diversity metric. These changes will be assessed using a regression based kernel association test. Unrarefied phyla, genera, species, and imputed functional genes in pathways will be center log ratio transformed to better approximate a normal distribution. Linear mixed models adjusting for sex, age, body fat mass, energy intake, and baseline measures will be used to evaluate differences in response between diets for alpha diversity, individual phyla, genera, species, and imputed functional gene pathways.
Time frame: At baseline and after 3 months daily kefir consumption
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Ancillary studies