A Phase 1/2 interventional study of Beta-glucan and Placebo in Autologous Haemopoietic Stem Cell Transplant, sponsored by University of Florida. Terminated at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by University of Florida · Phase 1/2, Interventional, and Treatment
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).
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.
1,912 studies on the registry are indexed under Fatigue; 381 are open to participants now.
This study's enrollment of 3 is below the median of 53 across 1,479 interventional studies indexed under Fatigue.
Browse Fatigue studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
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Exclusion Criteria:
500 mg/d of beta-glucan
Dietary Supplement: Beta-glucan
500 mg/d of cellulose
Dietary Supplement: Placebo
2, 250 mg capsules of beta-glucan per day
2, 250 mg capsules of cellulose
Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool
change in global fatigue score
Time frame: 8 weeks
Frequency of adverse events per group
number of adverse events
Time frame: 8 weeks
Change in serum levels of TNF-α, IL-1β, and IFN-γ
Inflammatory cytokines
Time frame: 8 weeks
Change in Functional Assessment of Cancer Therapy - Bone MarrowTransplantation (FACT-BMT) score
Assessment of Quality of Life
Time frame: 8 weeks
Change in General Sleep Disturbances Scale (GSDS) score
Assessment of sleep disturbance
Time frame: 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
Assessment of pain
Time frame: 8 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score
Assessment of mood including anxiety and depression.
Time frame: 8 weeks
Change in the Godin Leisure Form (GLF) score
Assessment of physical activity
Time frame: 8 weeks
Plan to share: Undecided — Not yet determined.
No publications or documents are linked to this record.
Ran from Feb 2023 to primary completion in Aug 2023, 6 months.
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This study is terminated, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Beta-Glucans