Beta-glucan and Fatigue in HSCT Survivors

Phase 1

Terminated

• Conditions: Autologous Haemopoietic Stem Cell Transplant
• Interventions: Dietary Supplement: Beta-glucan; Dietary Supplement: Placebo

• Registration Number: NCT05524688
• Lead Sponsor: University of Florida

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.

Study Timeline

• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-08-30
• Study First Posted: 2022-09-01
• Study Start: 2023-02-10
• Primary Completion: 2023-08-28
• Study Completion: 2023-08-28
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Beta-glucan	Beta-glucan	500 mg/d of beta-glucan
Placebo	Placebo	500 mg/d of cellulose

Primary Outcome Measures

Name	Time	Method
Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool	8 weeks	change in global fatigue score

Secondary Outcome Measures

Name	Time	Method
Change in Functional Assessment of Cancer Therapy - Bone MarrowTransplantation (FACT-BMT) score	8 weeks	Assessment of Quality of Life
Frequency of adverse events per group	8 weeks	number of adverse events
Change in General Sleep Disturbances Scale (GSDS) score	8 weeks	Assessment of sleep disturbance
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 serum levels of TNF-α, IL-1β, and IFN-γ	8 weeks	Inflammatory cytokines
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

Trial Locations

Locations (1)

Shands at University of Florida; 🇺🇸 Gainesville, Florida, United States