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Hydrocortisone 1% cream for Colorectal Cancer

Phase 2
Waitlist Available
Led By Rebecca A. 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 surival follow up (6 months, 12 months, 18 months, and 24 months)
Awards & highlights

Study Summary

This trial will compare using Doxycycline, sunscreen, hydrocortisone cream, and a moisturizer to just using a moisturizer to see if it prevents or reduces the severity of skin rash caused by the drug Cetuximab.

Eligible Conditions
  • Colorectal Cancer
  • Head and Neck Cancers

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~surival follow up (6 months, 12 months, 18 months, and 24 months)
This trial's timeline: 3 weeks for screening, Varies for treatment, and surival follow up (6 months, 12 months, 18 months, and 24 months) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of Rash
Secondary outcome measures
Adherence to treatment regimen
Progression Free Survival
Quality of Life (QOL)

Trial Design

2Treatment groups
Experimental Treatment
Group I: Standard care groupExperimental Treatment2 Interventions
Patient will not receive preventive treatment but will be allowed to use sunscreen and moisturizer if desired.
Group II: Extensive treatment groupExperimental Treatment6 Interventions
Doxycycline capsule, 100 mg, taken twice daily; sunscreen SPF 30 or higher applied to exposed skin areas at least 30 minutes before going outdoors each morning; moisturizer applied to the face, hands, feet, neck, back, and chest each morning after sunscreen; Hydrocortisone 1% topical cream applied to the face, hands, feet, neck, back, and chest each evening. For patients with grade 1 rash, hydrocortisone 1% cream and clindamycin 1% gel (tetracycline antibiotic) are recommended for daily use. For patients with grade 2 rash, hydrocortisone cream and doxycycline 100mg twice daily or minocycline (tetracycline antibiotic) 100mg once daily is recommended. For patients with grade 3 rash, systemic steroid therapy (a Medrol dose-pack) will be added to the grade 2 treatment.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Methylprednisolone
FDA approved
Clindamycin
FDA approved
Doxycycline
FDA approved
Hydrocortisone
FDA approved

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
338 Previous Clinical Trials
75,960 Total Patients Enrolled
James Graham Brown Cancer CenterOTHER
43 Previous Clinical Trials
9,194 Total Patients Enrolled
Rebecca A. Redman, MDPrincipal InvestigatorJames Graham Brown Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients
Rebecca Redman 2013. "Skin Rash Study Before Chemotherapy in Colorectal & Head and Neck Cancer Patients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01874860.
~2 spots leftby Apr 2025
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