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

Primary Purpose

Plasma Cell Myeloma

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Best Practice
Kefir
Quality-of-Life Assessment
Questionnaire Administration
Sponsored by
Roswell Park Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Plasma Cell Myeloma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Roswell Park Cancer Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (commercial kefir beverage)

Arm II (usual diet)

Arm Description

Patients consume commercial kefir beverage daily for 3 months.

Patients maintain usual diet for 3 months.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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.

Full Information

First Posted
August 21, 2020
Last Updated
November 15, 2021
Sponsor
Roswell Park Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04530812
Brief Title
Fermented Milk Supplementation on Symptoms of Disease and Treatment in Patients With Multiple Myeloma
Official Title
Pilot Study of Fermented Milk Supplementation on Symptoms of Disease and Treatment in Patients With Multiple Myeloma
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Completed
Study Start Date
August 24, 2020 (Actual)
Primary Completion Date
July 27, 2021 (Actual)
Study Completion Date
August 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roswell Park Cancer Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Plasma Cell Myeloma

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (commercial kefir beverage)
Arm Type
Experimental
Arm Description
Patients consume commercial kefir beverage daily for 3 months.
Arm Title
Arm II (usual diet)
Arm Type
Active Comparator
Arm Description
Patients maintain usual diet for 3 months.
Intervention Type
Other
Intervention Name(s)
Best Practice
Other Intervention Name(s)
standard of care, standard therapy
Intervention Description
Maintain usual diet
Intervention Type
Dietary Supplement
Intervention Name(s)
Kefir
Other Intervention Name(s)
Kephir
Intervention Description
Consume commercial kefir beverage
Intervention Type
Other
Intervention Name(s)
Quality-of-Life Assessment
Other Intervention Name(s)
Quality of Life Assessment
Intervention Description
Ancillary studies
Intervention Type
Other
Intervention Name(s)
Questionnaire Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Changes in levels of parathyroid hormone (PTH)
Description
Collect Changes in values of PTH from baseline to week 12in patients who added kefir to their diet
Time Frame
Week 12
Title
Change in quality of life
Description
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
Secondary Outcome Measure Information:
Title
Overall Gut microbial community structure
Description
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
Other Pre-specified Outcome Measures:
Title
Symptom Improvement
Description
Feasibility of a probiotic lifestyle intervention in multiple myeloma patients
Time Frame
Up to 30 days post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Hillengass
Organizational Affiliation
Roswell Park Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Roswell Park Cancer Institute
City
Buffalo
State/Province
New York
ZIP/Postal Code
14263
Country
United States

12. IPD Sharing Statement

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

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