Fermented Milk Supplementation on Symptoms of Disease and Treatment in Patients With Multiple Myeloma

Not Applicable

Completed

• Conditions: Plasma Cell Myeloma
• Interventions: Dietary Supplement: Kefir; Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

• Registration Number: NCT04530812
• Lead Sponsor: Roswell Park Cancer Institute

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2020-08-21
• Study Start: 2020-08-24
• Study First Submitted QC: 2020-08-25
• Study First Posted: 2020-08-28
• Primary Completion: 2021-07-27
• Study Completion: 2021-08-30
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-15
• Last Update Posted: 2021-11-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13

Inclusion Criteria

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
• Neutrophil values > 1,000/uL
• Diagnosis of multiple myeloma: on maintenance or continued treatment
• Show no signs of comorbidities, myeloma symptoms, or treatment side effects that would put them in danger when participating in the study according to the physician's discretion
• Able to understand and comply with study instructions, including willing to purchase and consume study beverage daily if in intervention arm or, avoid regular consumption of fermented dairy foods (kefir, yogurt, lassi, etc.) if in the control arm
• Understand the investigational nature of the study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria

• Allergies to milk
• Lactose intolerance
• Current habitual (> 3 times per week) consumption of yogurt, kefir, lassi, over-the-counter probiotic dietary supplements
• Chronic inflammatory bowel disease
• Autologous stem cell transplantation or chimeric antigen receptor (CAR)-T cell therapy within the last 6 months
• Prior allogeneic stem cell transplantation
• Major comorbidities that would cause danger to the patient when participating in the study
• Pregnant or nursing female participants
• Unwilling or unable to follow protocol requirements
• Any condition which in the investigator's opinion deems the participant an unsuitable candidate to take part in study intervention
• Adults unable to consent
• Individuals who are not yet adults (infants, children, teenagers)
• Pregnant women
• Prisoners

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (usual diet)	Quality-of-Life Assessment	Patients maintain usual diet for 3 months.
Arm I (commercial kefir beverage)	Kefir	Patients consume commercial kefir beverage daily for 3 months.
Arm I (commercial kefir beverage)	Quality-of-Life Assessment	Patients consume commercial kefir beverage daily for 3 months.
Arm II (usual diet)	Best Practice	Patients maintain usual diet for 3 months.
Arm I (commercial kefir beverage)	Questionnaire Administration	Patients consume commercial kefir beverage daily for 3 months.
Arm II (usual diet)	Questionnaire Administration	Patients maintain usual diet for 3 months.

Primary Outcome Measures

Name	Time	Method
Changes in levels of parathyroid hormone (PTH)	Week 12	Collect Changes in values of PTH from baseline to week 12in patients who added kefir to their diet
Change in quality of life	Up to 30 days post-intervention	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

Secondary Outcome Measures

Name	Time	Method
Overall Gut microbial community structure	At baseline and after 3 months daily kefir consumption	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.

Trial Locations

Locations (1)

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States