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

NCT04530812 | Completed DMC

• 2 other identifiers: I 657720NCI-2020-05777
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Plasma Cell Myeloma

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (1)

• Overall Gut microbial community structure

  At baseline and after 3 months daily kefir consumption

Other Outcomes (1)

• Symptom Improvement

  Up to 30 days post-intervention

Study Arms (2)

Arm I (commercial kefir beverage)

EXPERIMENTAL

Patients consume commercial kefir beverage daily for 3 months.

Dietary Supplement: Kefir; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Arm II (usual diet)

ACTIVE COMPARATOR

Patients maintain usual diet for 3 months.

Other: Best Practice; Other: Quality-of-Life Assessment; Other: Questionnaire Administration

Interventions

Best Practice OTHER

Maintain usual diet

Also known as: standard of care, standard therapy

Arm II (usual diet)

Kefir DIETARY_SUPPLEMENT

Consume commercial kefir beverage

Also known as: Kephir

Arm I (commercial kefir beverage)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Arm I (commercial kefir beverage); Arm II (usual diet)

Questionnaire Administration OTHER

Ancillary studies

Arm I (commercial kefir beverage); Arm II (usual diet)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Roswell Park Cancer Institute: lead

Study Sites (1)

Roswell Park Cancer Institute

Buffalo, New York, 14263, United States

Location

MeSH Terms

Conditions

Multiple Myeloma

Interventions

Practice Guidelines as Topic; Standard of Care; Kefir

Condition Hierarchy (Ancestors)

Neoplasms, Plasma Cell; Neoplasms by Histologic Type; Neoplasms; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemorrhagic Disorders; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care; Fermented Beverages; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Cultured Milk Products; Milk; Fermented Foods; Dairy Products; Food; Food and Beverages

Study Officials

• Jens Hillengass

  Roswell Park Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2020
• First Posted: August 28, 2020
• Study Start: August 24, 2020
• Primary Completion: July 27, 2021
• Study Completion: August 30, 2021
• Last Updated: November 16, 2021

Record last verified: 2021-11

Locations

US (1)