Beta-glucan and Fatigue in HSCT Survivors

NCT ID: NCT05524688

Last Updated: 2023-10-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-10
• Study Completion Date: 2023-08-28

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.

Conditions

Autologous Haemopoietic Stem Cell Transplant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Beta-glucan

500 mg/d of beta-glucan

Group Type: EXPERIMENTAL

Beta-glucan

Intervention Type: DIETARY_SUPPLEMENT

2, 250 mg capsules of beta-glucan per day

Placebo

500 mg/d of cellulose

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

2, 250 mg capsules of cellulose

Interventions

Beta-glucan

2, 250 mg capsules of beta-glucan per day

Intervention Type: DIETARY_SUPPLEMENT

Placebo

2, 250 mg capsules of cellulose

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lallemand Bio-Ingredients

OTHER

Sponsor Role: collaborator

University of Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nosha Farhadfar, MD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Wendy Dahl, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

Shands at University of Florida

Gainesville, Florida, United States

Countries

United States

Other Identifiers

IRB202102622

Identifier Type: -

Identifier Source: org_study_id