Clinical trial NCT05524688: Beta-glucan and Fatigue in HSCT Survivors
Official title: Yeast-derived Beta-glucan Supplementation for Fatigue Symptoms in Autologous Haemopoietic Stem Cell Transplant Survivors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Autologous Haemopoietic Stem Cell Transplant
Keywords: HSCT
fatigue
beta-glucan
quality of life
inflammation
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Lallemand Bio-Ingredients
First posted: 2022-09-01
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool
timeFrame: 8 weeks
Secondary outcomes:
measure: Frequency of adverse events per group
timeFrame: 8 weeks
measure: Change in serum levels of TNF-α, IL-1β, and IFN-γ
timeFrame: 8 weeks
measure: Change in Functional Assessment of Cancer Therapy - Bone MarrowTransplantation (FACT-BMT) score
timeFrame: 8 weeks
measure: Change in General Sleep Disturbances Scale (GSDS) score
timeFrame: 8 weeks
measure: 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
timeFrame: 8 weeks
measure: Change in Hospital Anxiety and Depression Scale (HADS) score
timeFrame: 8 weeks
measure: Change in the Godin Leisure Form (GLF) score
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands at University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Nosha Farhadfar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: Wendy Dahl, PhD
role: PRINCIPAL_INVESTIGATOR
References: