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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients will have an Eastern Cooperative Oncology Group performance status of 0 or 1.
Patients will be considered for inclusion if a subsequent biopsy or surgical resection are planned as part of their best care treatment.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 day to 4 weeks.
Awards & highlights
Study Summary
This trial will test how well a potential new cancer drug works against oral cancer cells.
Who is the study for?
This trial is for adults with white or red spots/lesions in the mouth, diagnosed as oral cancer or precancer. It's open to smokers and non-smokers who are generally healthy, have good organ function, and no severe illnesses. Pregnant women, breastfeeding mothers, those unable to consent, on steroids recently or with hearing/language issues can't join.Check my eligibility
What is being tested?
The study tests MASL's effectiveness against oral cancer by comparing it to a placebo. Participants will be randomly assigned to receive either MASL or an inactive substance without knowing which one they're getting.See study design
What are the potential side effects?
Potential side effects of MASL aren't detailed here but could include typical drug reactions like allergic responses, gastrointestinal discomforts (like nausea), fatigue, and possible impacts on liver enzymes based on standard blood test monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully active or restricted in physically strenuous activity but can do light work.
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I am scheduled for a biopsy or surgery as part of my treatment plan.
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I am 18 or older and can give my consent.
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I have white or red spots in my mouth that may be cancer or precancer.
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I do not have any ongoing infections, unstable illnesses, or serious medical conditions.
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My condition can be at any stage of progression.
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My blood tests for liver and kidney function are normal.
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My oral lesions are confirmed as OSCC or specific types of leukoplakia, erythroplakia, papillomas, or lichen planus.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 day to 4 weeks.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 day to 4 weeks.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pre-treatment OSCC morphology and PDPN expression
Secondary outcome measures
Post-treatment OSCC morphology and PDPN expression
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: MASL treatedExperimental Treatment1 Intervention
Patients treated with lozenge containing MASL
Group II: Placebo treatedPlacebo Group1 Intervention
Patients treated with lozenge without MASL
Find a Location
Who is running the clinical trial?
Rowan UniversityLead Sponsor
22 Previous Clinical Trials
2,785 Total Patients Enrolled
Rutgers UniversityOTHER
113 Previous Clinical Trials
2,804,079 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have used a topical steroid in the last 2 weeks.I am fully active or restricted in physically strenuous activity but can do light work.I am scheduled for a biopsy or surgery as part of my treatment plan.You have difficulty hearing or communicating verbally.I am 18 or older and can give my consent.Both smokers and non-smokers can participate.I have white or red spots in my mouth that may be cancer or precancer.I do not have any ongoing infections, unstable illnesses, or serious medical conditions.You are currently breastfeeding a baby.I cannot make medical decisions due to cognitive impairments.My condition can be at any stage of progression.My blood tests for liver and kidney function are normal.My oral lesions are confirmed as OSCC or specific types of leukoplakia, erythroplakia, papillomas, or lichen planus.
Research Study Groups:
This trial has the following groups:- Group 1: MASL treated
- Group 2: Placebo treated
Awards:
This trial has 0 awards, including: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.
Is this medical experiment accepting new participants?
"Indeed, clinicaltrials.gov documents that this ongoing trial is in need of volunteers. It was initially posted on January 29th 2021 and most recently updated on April 26th 2022. The researchers are searching for 20 participants across 4 sites to complete the study."
Answered by AI
What is the upper limit for patient involvement in this trial?
"Affirmative. According to the clinicaltrials.gov platform, this medical trial is still recruiting participants since its initial posting on January 29th 2021 and last update on April 26th 2022. The research team needs to recruit 20 patients from 4 different sites."
Answered by AI
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