Fermented Milk Supplementation on Symptoms of Disease and Treatment in Patients With Multiple Myeloma
NCT ID: NCT04530812
Last Updated: 2021-11-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
13 participants
INTERVENTIONAL
2020-08-24
2021-08-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm I (commercial kefir beverage)
Patients consume commercial kefir beverage daily for 3 months.
Kefir
Consume commercial kefir beverage
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Arm II (usual diet)
Patients maintain usual diet for 3 months.
Best Practice
Maintain usual diet
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Interventions
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Best Practice
Maintain usual diet
Kefir
Consume commercial kefir beverage
Quality-of-Life Assessment
Ancillary studies
Questionnaire Administration
Ancillary studies
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Roswell Park Cancer Institute
OTHER
Responsible Party
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Principal Investigators
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Jens Hillengass
Role: PRINCIPAL_INVESTIGATOR
Roswell Park Cancer Institute
Locations
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Roswell Park Cancer Institute
Buffalo, New York, United States
Countries
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Other Identifiers
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NCI-2020-05777
Identifier Type: REGISTRY
Identifier Source: secondary_id
I 657720
Identifier Type: OTHER
Identifier Source: secondary_id
I 657720
Identifier Type: -
Identifier Source: org_study_id