Beta-glucan and Fatigue in HSCT Survivors

University of Florida

Status and phase: Terminated; Phase 2; Phase 1

Conditions: Autologous Haemopoietic Stem Cell Transplant

Treatments: Dietary Supplement: Beta-glucan; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05524688

IRB202102622

Details and patient eligibility

About

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).

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups, including a placebo group

Beta-glucan

Experimental group

Description:

500 mg/d of beta-glucan

Treatment:

Dietary Supplement: Beta-glucan

Placebo

Placebo Comparator group

Description:

500 mg/d of cellulose

Treatment:

Dietary Supplement: Placebo