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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2020-05777 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| I 657720 | Other Identifier | Roswell Park Cancer Institute |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (commercial kefir beverage) | Experimental | Patients consume commercial kefir beverage daily for 3 months. |
|
| Arm II (usual diet) | Active Comparator | Patients maintain usual diet for 3 months. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Best Practice | Other | Maintain usual diet |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | Up to 30 days post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Symptom Improvement | Feasibility of a probiotic lifestyle intervention in multiple myeloma patients | Up to 30 days post-intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Hillengass | Roswell Park Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Roswell Park Cancer Institute | Buffalo | New York | 14263 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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| ID | Term |
|---|---|
| D017410 | Practice Guidelines as Topic |
| D059039 | Standard of Care |
| D000070716 | Kefir |
| ID | Term |
|---|---|
| D017408 | Guidelines as Topic |
| D011785 | Quality Assurance, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
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| Kefir | Dietary Supplement | Consume commercial kefir beverage |
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| Quality-of-Life Assessment | Other | Ancillary studies |
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| Questionnaire Administration | Other | Ancillary studies |
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| At baseline and after 3 months daily kefir consumption |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D017530 | Health Care Quality, Access, and Evaluation |
| D019984 | Quality Indicators, Health Care |
| D000088082 | Fermented Beverages |
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D043302 | Cultured Milk Products |
| D008892 | Milk |
| D000074421 | Fermented Foods |
| D003611 | Dairy Products |
| D005502 | Food |
| D019602 | Food and Beverages |