Pilot Study of Fermented Milk Supplementation on Symptoms of Disease and Treatment in Patients With Multiple Myeloma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- Changes in levels of parathyroid hormone (PTH)
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Arm II (usual diet)
Patients maintain usual diet for 3 months.
干预措施: Quality-of-Life Assessment (Other)
Arm II (usual diet)
Patients maintain usual diet for 3 months.
干预措施: Questionnaire Administration (Other)
Arm I (commercial kefir beverage)
Patients consume commercial kefir beverage daily for 3 months.
干预措施: Kefir (Dietary Supplement)
Arm I (commercial kefir beverage)
Patients consume commercial kefir beverage daily for 3 months.
干预措施: Quality-of-Life Assessment (Other)
Arm I (commercial kefir beverage)
Patients consume commercial kefir beverage daily for 3 months.
干预措施: Questionnaire Administration (Other)
Arm II (usual diet)
Patients maintain usual diet for 3 months.
干预措施: Best Practice (Other)
结局指标
主要结局
Changes in levels of parathyroid hormone (PTH)
时间窗: 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
时间窗: 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
次要结局
- Overall Gut microbial community structure(At baseline and after 3 months daily kefir consumption)