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Grape extract for Mouth sores

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
No Placebo-Only Group
All Individual Drugs Already Approved
Approved for 10 Other Conditions

Summary

This trial is testing whether grape powder can help prevent painful mouth sores in patients receiving treatment for head and neck cancer. The grape powder contains tiny particles that might reduce inflammation and support the immune system.

Eligible Conditions
  • Mouth sores
  • Head and Neck Cancers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~total followup of six months
This trial's timeline: 3 weeks for screening, Varies for treatment, and total followup of six months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Pain caused by oral mucositis
Secondary study objectives
Level of immune biomarkers in blood
Level of immune biomarkers in mucosal tissue

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.

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
345 Previous Clinical Trials
77,355 Total Patients Enrolled
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,136 Total Patients Enrolled
Rebecca Redman, MDPrincipal InvestigatorJames Graham Brown Cancer Center, University of Louisville
~5 spots leftby Nov 2025
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