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Beta-glucan and Fatigue in HSCT Survivors

Primary Purpose

Autologous Haemopoietic Stem Cell Transplant

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Beta-glucan
Placebo
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Autologous Haemopoietic Stem Cell Transplant focused on measuring HSCT, fatigue, beta-glucan, quality of life, inflammation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Shands at University of Florida

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Beta-glucan

Placebo

Arm Description

500 mg/d of beta-glucan

500 mg/d of cellulose

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2022
Last Updated
October 20, 2023
Sponsor
University of Florida
Collaborators
Lallemand Bio-Ingredients
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1. Study Identification

Unique Protocol Identification Number
NCT05524688
Brief Title
Beta-glucan and Fatigue in HSCT Survivors
Official Title
Yeast-derived Beta-glucan Supplementation for Fatigue Symptoms in Autologous Haemopoietic Stem Cell Transplant Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Terminated
Why Stopped
Departure of PI clinician from institution.
Study Start Date
February 10, 2023 (Actual)
Primary Completion Date
August 28, 2023 (Actual)
Study Completion Date
August 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Lallemand Bio-Ingredients

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autologous Haemopoietic Stem Cell Transplant
Keywords
HSCT, fatigue, beta-glucan, quality of life, inflammation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
3 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Beta-glucan
Arm Type
Experimental
Arm Description
500 mg/d of beta-glucan
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
500 mg/d of cellulose
Intervention Type
Dietary Supplement
Intervention Name(s)
Beta-glucan
Intervention Description
2, 250 mg capsules of beta-glucan per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
2, 250 mg capsules of cellulose
Primary Outcome Measure Information:
Title
Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool
Description
change in global fatigue score
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Frequency of adverse events per group
Description
number of adverse events
Time Frame
8 weeks
Title
Change in serum levels of TNF-α, IL-1β, and IFN-γ
Description
Inflammatory cytokines
Time Frame
8 weeks
Title
Change in Functional Assessment of Cancer Therapy - Bone MarrowTransplantation (FACT-BMT) score
Description
Assessment of Quality of Life
Time Frame
8 weeks
Title
Change in General Sleep Disturbances Scale (GSDS) score
Description
Assessment of sleep disturbance
Time Frame
8 weeks
Title
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
Description
Assessment of pain
Time Frame
8 weeks
Title
Change in Hospital Anxiety and Depression Scale (HADS) score
Description
Assessment of mood including anxiety and depression.
Time Frame
8 weeks
Title
Change in the Godin Leisure Form (GLF) score
Description
Assessment of physical activity
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nosha Farhadfar, MD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Wendy Dahl, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shands at University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Not yet determined.

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Beta-glucan and Fatigue in HSCT Survivors

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