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Beta-Glucan for Melanoma
N/A
Recruiting
Led By Kelly M McMasters, MD
Research Sponsored by Kelly McMasters
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
ECOG performance status of 0-3
18 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up blood for analysis will be drawn at baseline (day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
Awards & highlights
Study Summary
This trial will study how beta-glucan, a type of dietary fiber, affects the immune system in people with melanoma.
Who is the study for?
This trial is for adults with Stage III-IV melanoma who are starting or have been on Pembrolizumab therapy. They should not currently have the disease, be new to treatment or haven't had it in over 6 months, and must be able to swallow pills. People with a history of beta-glucan sensitivity, other cancers, immune suppression therapy, serious illnesses like heart failure or infections, or certain mental health issues can't join.Check my eligibility
What is being tested?
The study is testing how Beta-Glucan affects the immune response in patients taking Pembrolizumab for advanced melanoma. It aims to see if this combination improves outcomes compared to what's expected from Pembrolizumab alone.See study design
What are the potential side effects?
While specific side effects of Beta-Glucan combined with Pembrolizumab aren't detailed here, potential risks may include allergic reactions due to Beta-Glucan and typical immunotherapy-related side effects such as fatigue, skin reactions, digestive problems and changes in liver function.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I can care for myself but may not be able to do heavy physical work.
Select...
I am 18 years old or older.
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I have stage III-IV melanoma and am on Pembrolizumab with no signs of active disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ blood for analysis will be drawn at baseline (day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~blood for analysis will be drawn at baseline (day 0), 3 weeks post pembrolizumab treatment, and 3 weeks post pembrolizumab plus oral beta-glucan
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Changes in absolute number of intracellular cytokine expression markers
Changes in absolute number of lymphocyte cell surface expression markers
Changes in fluorescent intensity of intracellular cytokine expression markers
+3 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: TreatmentExperimental Treatment1 Intervention
All subjects will undergo 21 days of Pembrolizumab followed by 21 days of beta-glucan.
Pembrolizumab: 200 mg/100mL IV in three week intervals
Beta-glucan: 500mg (1 capsule) by mouth twice a day for 21 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Beta-Glucan
2018
N/A
~60
Find a Location
Who is running the clinical trial?
Kelly McMastersLead Sponsor
Kelly M McMasters, MDPrincipal InvestigatorUniversity of Louisville
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I can care for myself but may not be able to do heavy physical work.I am 18 years old or older.I am currently on continuous immunosuppressive medication.I have been diagnosed with mucosal melanoma.I can swallow pills.I haven't had any treatments, or it's been over 6 months since my last treatment.I do not have any severe illnesses that could interfere with the study.I have another type of cancer now or had one recently.I have stage III-IV melanoma and am on Pembrolizumab with no signs of active disease.I have not had serious autoimmune reactions or cancer recurrence in the last 6 weeks.You have had strong allergic reactions to beta-glucan in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many participants are being monitored during this research endeavor?
"Affirmative. Information available on clinicaltrials.gov asserts that this medical trial, first posted back in November 2020, is currently recruiting participants at one site with a need for 30 patients."
Answered by AI
Is recruitment currently underway for this experiment?
"Affirmative. Clinicaltrials.gov reveals that this trial was initially posted on November 3rd 2020, and is still actively recruiting participants with edits last made on January 7th 2022. 30 people need to be recruited at a single site in order for the study to continue."
Answered by AI
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