Autologous Haemopoietic Stem Cell Transplant
Conditions
Keywords
HSCT, fatigue, beta-glucan, quality of life, inflammation
Brief summary
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).
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTBeta-glucan
2, 250 mg capsules of beta-glucan per day
DIETARY_SUPPLEMENTPlacebo
2, 250 mg capsules of cellulose
Sponsors
Lallemand Bio-Ingredients
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* 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 3.0. * 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.
Exclusion criteria
* Have an active infection. * Have disease relapse. * Have absolute neutrophil count less than 500. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool | 8 weeks | change in global fatigue score |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in serum levels of TNF-α, IL-1β, and IFN-γ | 8 weeks | Inflammatory cytokines |
| Change in Functional Assessment of Cancer Therapy - Bone MarrowTransplantation (FACT-BMT) score | 8 weeks | Assessment of Quality of Life |
| Change in General Sleep Disturbances Scale (GSDS) score | 8 weeks | Assessment of sleep disturbance |
| Frequency of adverse events per group | 8 weeks | number of adverse events |
| Change in Hospital Anxiety and Depression Scale (HADS) score | 8 weeks | Assessment of mood including anxiety and depression. |
| Change in the Godin Leisure Form (GLF) score | 8 weeks | Assessment of physical activity |
| 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 | Assessment of pain |
Countries
United States
Outcome results
None listed