Autologous Haemopoietic Stem Cell TransplantPhase 1/2NCT05524688
Beta-glucan and Fatigue in HSCT Survivors
A Phase 1/2 study testing Beta-glucan in people with Autologous Haemopoietic Stem Cell Transplant, run by University of Florida at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Autologous Haemopoietic Stem Cell Transplant
- What is being tested?
- Beta-glucan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2023to 28 Aug 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Shands at University of Florida
Gainesville, Florida, 32608
About this study
Official title: Yeast-derived Beta-glucan Supplementation for Fatigue Symptoms in Autologous Haemopoietic Stem Cell Transplant Survivors
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).
Read the 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.
- Being tested
- Beta-glucan, Placebo
- Keywords
- HSCT, fatigue, beta-glucan, quality of life, inflammation
- Medical subject headings
- Fatigue, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beta-glucanDietary supplement
2, 250 mg capsules of beta-glucan per day
PlaceboDietary supplement
2, 250 mg capsules of cellulose
| Study group | Role | What they receive |
|---|---|---|
| Beta-glucan | Experimental | 500 mg/d of beta-glucan Receives: Dietary Supplement: Beta-glucan |
| Placebo | Placebo comparator | 500 mg/d of cellulose Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool
change in global fatigue score
Measured: 8 weeks
Secondary outcomes (7)
Frequency of adverse events per group
number of adverse events
Measured: 8 weeks
Change in serum levels of TNF-α, IL-1β, and IFN-γ
Inflammatory cytokines
Measured: 8 weeks
Change in Functional Assessment of Cancer Therapy - Bone MarrowTransplantation (FACT-BMT) score
Assessment of Quality of Life
Measured: 8 weeks
Change in General Sleep Disturbances Scale (GSDS) score
Assessment of sleep disturbance
Measured: 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
Assessment of pain
Measured: 8 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score
Assessment of mood including anxiety and depression.
Measured: 8 weeks
Change in the Godin Leisure Form (GLF) score
Assessment of physical activity
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start10 Feb 2023
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Why it stopped: Departure of PI clinician from institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autologous Haemopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- Lallemand Bio-Ingredients
- Responsible party
- Sponsor
- Investigators
- Nosha Farhadfar, MD, Principal investigator, University of FloridaWendy Dahl, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05524688
- Sponsor's protocol ID
- IRB202102622
- Status last verified
- Oct 2023
- First submitted
- 30 Aug 2022
- Last updated
- 24 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Not yet determined.
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yeast-derived Beta-glucan Supplementation for Fatigue Symptoms in Autologous Haemopoietic Stem Cell Transplant Survivors
- ClinicalTrials.gov ID
- NCT05524688
- Acronym / sponsor ID
- IRB202102622
- Keywords
- HSCT, fatigue, beta-glucan, quality of life, inflammation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of PI clinician from institution.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- Lallemand Bio-Ingredients
- Study start
- 10 Feb 2023 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta-glucan | Experimental | Dietary Supplement: Beta-glucan500 mg/d of beta-glucan |
| Placebo | Placebo comparator | Dietary Supplement: Placebo500 mg/d of cellulose |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Beta-glucan2, 250 mg capsules of beta-glucan per day | Dietary supplement | Beta-glucan |
| Placebo2, 250 mg capsules of cellulose | Dietary supplement | Placebo |
Primary outcome
Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool
Time frame: 8 weeks
change in global fatigue score
7 secondary outcomes
Frequency of adverse events per group
Time frame: 8 weeks
Change in serum levels of TNF-α, IL-1β, and IFN-γ
Time frame: 8 weeks
Change in Functional Assessment of Cancer Therapy - Bone MarrowTransplantation (FACT-BMT) score
Time frame: 8 weeks
Change in General Sleep Disturbances Scale (GSDS) score
Time frame: 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
Time frame: 8 weeks
Change in Hospital Anxiety and Depression Scale (HADS) score
Time frame: 8 weeks
Change in the Godin Leisure Form (GLF) score
Time frame: 8 weeks
Results and safety
The study was stopped early (reason given: Departure of PI clinician from institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2023.
- Individual participant dataSharing planned: Undecided. Not yet determined.
Related trials for Autologous Haemopoietic Stem Cell Transplant
Not yet recruitingPhase 3
A Trial Comparing Ramantamig and Daratumumab (Ramantamig-D) Versus Daratumumab, Bortezomib, Lenalidomide, and Dexamethasone in Participants With Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible
Multiple Myeloma
RecruitingPhase 2
Auto Stem Cell Transplant for Lymphoma Patients
Non-Hodgkin Lymphoma, Hodgkin Lymphoma
RecruitingPhase 3
A Study of Teclistamab in Combination With Daratumumab and Lenalidomide (Tec-DR) and Talquetamab in Combination With Daratumumab and Lenalidomide (Tal-DR) in Participants With Newly Diagnosed Multiple Myeloma
Multiple Myeloma
Not yet recruitingPhase 3
To Evaluate Safety and Efficacy of Anitocabtagene Autoleucel Versus Autologous Stem Cell Transplant in Newly Diagnosed Multiple Myeloma
Newly Diagnosed Multiple Myeloma
RecruitingPhase 2
Glofitamab as a Bridge to and/or Consolidation Post Autologous Stem Cell Transplant in Patients With Relapsed B Cell Lymphomas
Diffuse Large B Cell Lymphoma Refractory
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nosha Farhadfar, MD principal investigator
University of Florida
Wendy Dahl, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Beta-glucan in people with Autologous Haemopoietic Stem Cell Transplant, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 24 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Departure of PI clinician from institution.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in fatigue as assessed by Brief Fatigue Inventory (BFI) tool (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2023.