Beta-glucan and Fatigue in HSCT Survivors

Yeast-derived Beta-glucan Supplementation for Fatigue Symptoms in Autologous Haemopoietic Stem Cell Transplant Survivors

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).

Study Overview

• Status: Terminated
• Conditions: Autologous Haemopoietic Stem Cell Transplant
• Intervention / Treatment: Dietary supplement: Beta-glucan; Dietary supplement: Placebo

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • Shands at University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beta-glucan; 500 mg/d of beta-glucan	Dietary supplement: Beta-glucan; 2, 250 mg capsules of beta-glucan per day
Placebo Comparator: Placebo; 500 mg/d of cellulose	Dietary supplement: Placebo; 2, 250 mg capsules of cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool	change in global fatigue score	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of adverse events per group	number of adverse events	8 weeks
Change in serum levels of TNF-α, IL-1β, and IFN-γ	Inflammatory cytokines	8 weeks
Change in Functional Assessment of Cancer Therapy - Bone MarrowTransplantation (FACT-BMT) score	Assessment of Quality of Life	8 weeks
Change in General Sleep Disturbances Scale (GSDS) score	Assessment of sleep disturbance	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	8 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score	Assessment of mood including anxiety and depression.	8 weeks
Change in the Godin Leisure Form (GLF) score	Assessment of physical activity	8 weeks

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: Lallemand Bio-Ingredients
• Investigators: Principal Investigator: Nosha Farhadfar, MD, University of Florida; Principal Investigator: Wendy Dahl, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2023
• Primary Completion (Actual): August 28, 2023
• Study Completion (Actual): August 28, 2023

Study Registration Dates

• First Submitted: August 30, 2022
• First Submitted That Met QC Criteria: August 30, 2022
• First Posted (Actual): September 1, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: fatigue; quality of life; inflammation; HSCT; beta-glucan
• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: IRB202102622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Not yet determined.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No