Beta-glucan and Fatigue in HSCT Survivors

Phase 2TerminatedNCT05524688

University of Florida3 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Autologous Haemopoietic Stem Cell Transplant

Interventions

Beta-glucanDIETARY_SUPPLEMENT

2, 250 mg capsules of beta-glucan per day

PlaceboDIETARY_SUPPLEMENT

2, 250 mg capsules of cellulose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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

Locations (1)

Shands at University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool

change in global fatigue score

Time frame: 8 weeks

Secondary Outcomes

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

Data from ClinicalTrials.gov

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