Yeast-derived Beta-glucan Supplementation for Fatigue Symptoms in Autologous Haemopoietic Stem Cell Transplant Survivors
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool
研究概览
简要总结
This is a single-center, randomized, double-blind, placebo-controlled study exploring the effects of a yeast-derived β-glucan on clinically significant fatigue among survivors of autologous HCT due to multiple myeloma. The primary aim is to evaluate the effect of β-glucan supplementation on changes in fatigue symptoms, as assessed by the Brief Fatigue Inventory (BFI) global fatigue score, by testing the differences in changes in scores from baseline to the mid-point (mean of weeks 1-4) and to the end of the intervention (mean of weeks 5-8).
详细描述
Fatigue is one of the most prevalent and distressing complications among hematopoietic cell transplantation HCT survivors, affecting up to 80% of patients. Fatigue has a significant negative impact on the physical, functional, social, and emotional domains of quality of life. Therefore, special attention should be directed toward therapeutic interventions in reducing persistent fatigue, which in turn improves quality of life of this patient population. Research is needed to determine if yeast-derived β-glucan regulates inflammatory disruption and fatigue in patient populations. This study will investigate the efficacy of β-glucan supplementation on fatigue symptoms in autologous HCT survivors due to multiple myeloma. The primary aim is to evaluate the effect of β-glucan supplementation on changes in fatigue symptoms, as assessed by the BFI global fatigue score, by testing the differences in changes in scores from baseline to the mid-point (mean of weeks 1-4) and to the end of the intervention (mean of weeks 5-8). Secondary objectives will be to evaluate tolerability, adverse events, inflammatory cytokines, quality of life, sleep disturbance, pain, anxiety, and depression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be ≥ 18 years of age.
- •Be an autologous HSCT survivor with clinically significant fatigue (determined post-consent). Clinically significant fatigue is defined as BFI global score greater than 3.
- •Have a medical history of the first autologous HSCT due to multiple myeloma approximately 30 days before starting the study intervention.
- •Be willing and able to provide written informed consent.
- •Be willing and able to comply with all the study-related procedures, including attending study visits for the blood draws, intake of the study supplement, and completing study questionnaires.
排除标准
- •Have an active infection.
- •Have disease relapse.
- •Have absolute neutrophil count less than
- •Have anemia and thrombocytopenia requiring transfusions.
- •Have an untreated medical condition that could clinically explain fatigue in this population (i.e., untreated hypothyroidism).
- •Have begun to take antidepressants less than 30 days from enrollment.
- •Demonstrate an inability to comply with the study and/or follow-up procedures.
- •Use probiotic supplements. The subjects can participate if they are willing to stop taking probiotics. A one-month withdrawal from probiotics is required
结局指标
主要结局
Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool
时间窗: 8 weeks
change in global fatigue score
次要结局
- Frequency of adverse events per group(8 weeks)
- Change in Functional Assessment of Cancer Therapy - Bone MarrowTransplantation (FACT-BMT) score(8 weeks)
- Change in General Sleep Disturbances Scale (GSDS) score(8 weeks)
- Change in Hospital Anxiety and Depression Scale (HADS) score(8 weeks)
- Change in the Godin Leisure Form (GLF) score(8 weeks)
- Change in serum levels of TNF-α, IL-1β, and IFN-γ(8 weeks)
- Change in Global07, from PROMIS® Numeric Rating Scale v.1.0 - Pain Intensity 1a plus PAININ20, from PROMIS - Ca Item Bank v1.1 - Pain Interference score(8 weeks)