NCT05524688

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

February 10, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 28, 2023

Completed
Last Updated

October 24, 2023

Status Verified

October 1, 2023

Enrollment Period

7 months

First QC Date

August 30, 2022

Last Update Submit

October 20, 2023

Conditions

Autologous Haemopoietic Stem Cell Transplant

Keywords

HSCTfatiguebeta-glucanquality of lifeinflammation

Outcome Measures

Primary Outcomes (1)

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

    change in global fatigue score

    8 weeks

Secondary Outcomes (7)

  • Frequency of adverse events per group

    8 weeks

  • Change in serum levels of TNF-α, IL-1β, and IFN-γ

    8 weeks

  • Change in Functional Assessment of Cancer Therapy - Bone MarrowTransplantation (FACT-BMT) score

    8 weeks

  • Change in General Sleep Disturbances Scale (GSDS) score

    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

    8 weeks

  • +2 more secondary outcomes

Study Arms (2)

Beta-glucan

EXPERIMENTAL

500 mg/d of beta-glucan

Dietary Supplement: Beta-glucan

Placebo

PLACEBO COMPARATOR

500 mg/d of cellulose

Dietary Supplement: Placebo

Interventions

Beta-glucanDIETARY_SUPPLEMENT

2, 250 mg capsules of beta-glucan per day

Beta-glucan
PlaceboDIETARY_SUPPLEMENT

2, 250 mg capsules of cellulose

Placebo

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shands at University of Florida

Gainesville, Florida, 32608, United States

Location

MeSH Terms

Conditions

FatigueInflammation

Interventions

beta-Glucans

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Intervention Hierarchy (Ancestors)

GlucansPolysaccharidesCarbohydrates

Study Officials

  • Nosha Farhadfar, MD

    University of Florida

    PRINCIPAL INVESTIGATOR

  • Wendy Dahl, PhD

    University of Florida

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 1, 2022

Study Start

February 10, 2023

Primary Completion

August 28, 2023

Study Completion

August 28, 2023

Last Updated

October 24, 2023

Record last verified: 2023-10

Locations

US(1)