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Grape extract for Head and Neck Cancers
Phase 1
Waitlist Available
Led By Rebecca Redman, MD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up total followup of six months
Awards & highlights
Study Summary
This trial will study whether grape powder can help reduce inflammation and mouth sores during radiation and chemotherapy for head and neck tumors.
Eligible Conditions
- Head and Neck Cancers
- Mouth Sore
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ total followup of six months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~total followup of six months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pain caused by oral mucositis
Secondary outcome measures
Level of immune biomarkers in blood
Level of immune biomarkers in mucosal tissue
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: 1 - Grape extractExperimental Treatment1 Intervention
Grape extract self-administered daily by mouth for 35 days during chemoradiation therapy.
Group II: 2 - Lortab, Fentanyl patch, mouthwashActive Control1 Intervention
Standard oral mucositis therapy such as pain medication and anti-fungal mouth washes will be prescribed according to product labels.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Grape extract
2012
Completed Phase 1
~60
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,924 Total Patients Enrolled
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,158 Total Patients Enrolled
Rebecca Redman, MDPrincipal InvestigatorJames Graham Brown Cancer Center, University of Louisville
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