Melanoma Stage IIISupplementsNutrition and dietDietary supplement
What this study is
The purpose of this study is to determine how beta-glucan affects the immune system in subjects with melanoma.
What's being tested
- Beta-Glucan
Intervention · DIETARY SUPPLEMENT
500mg (1 capsule) by mouth twice a day for 21 days.
Study details
- Sponsor
- Kelly McMasters
- Conditions
- Melanoma Stage III · Melanoma Stage IV
- Enrolling
- 30 people
- Starts
- 2020-11-03
- Est. completion
- 2027-01-15
- Design
- Open-label, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Any patients with suspected (clinical) or definitive (tissue) diagnosis of Stage III-IV melanoma starting or continuing adjuvant Pembrolizumab without active evidence of disease (NED).
- Must be treatment naïve or have had treatment no less than 6 months prior to enrollment
- 18 years or older
- Must be able to take pills
- ECOG performance status of 0-3
- Ability to understand and willingness to sign a written informed consent
- Members of all racial and ethnic groups are eligible for this study
You can't join if
- History of hypersensitivity reactions attributed to beta-glucan
- Patients receiving continuous or other ongoing immunosuppressive therapy
- Uncontrolled intercurrent illness including, but not limited to, autoimmune diseases, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Any patients who have serious autoimmune toxicity during the study period, or those who have disease recurrence during the 6-week study period should be excluded and analyzed separately
- Patients with mucosal melanoma
- Patients with concurrent malignancy or recent history thereof
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Louisville
Louisville, Kentucky, United States
- Matthew Woeste, MD · Contact502-852-0325matthew.woeste@louisville.edu
Recruiting
Study team
Sponsor
Kelly McMasters
Study ID 20.0614
Principal investigator
Kelly M McMasters, MD
University of Louisville
Have questions? The contacts above can answer them before you apply.
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.