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Beta-glucan and Fatigue in HSCT Survivors

NCT05524688 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2023-10-24

No results posted yet for this study

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).

Conditions

  • Autologous Haemopoietic Stem Cell Transplant

Interventions

DIETARY_SUPPLEMENT

Beta-glucan

2, 250 mg capsules of beta-glucan per day

DIETARY_SUPPLEMENT

Placebo

2, 250 mg capsules of cellulose

Sponsors & Collaborators

  • Lallemand Bio-Ingredients

    collaborator OTHER

  • University of Florida

    lead OTHER

Principal Investigators

  • Nosha Farhadfar, MD · University of Florida

  • Wendy Dahl, PhD · University of Florida

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-10
Primary Completion
2023-08-28
Completion
2023-08-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05524688 on ClinicalTrials.gov