What side effects are associated with this type of intervention?

EGFR inhibitors, commonly used in cancer treatment, can cause a range of side effects including skin rashes, ocular toxicity, and trichomegaly of the eyelashes. Chemotherapy, another common cancer treatment, often leads to side effects such as nausea, vomiting, diarrhea, myelosuppression, and fatigue. Immunotherapy can result in immune-related adverse effects like colitis, dermatitis, and pneumonitis. Specific to ketoconazole, which is being studied for its potential to alleviate EGFR inhibitor-induced rash, side effects may include liver toxicity and adrenal insufficiency.

What prior FDA approvals exist?

The FDA has approved several treatments for managing side effects related to cancer therapies, particularly those involving EGFR inhibitors. For instance, cetuximab, an EGFR inhibitor used in combination with chemotherapy, has been approved for treating head and neck cancers. It is known to cause skin reactions, and managing these side effects is crucial for patient compliance and quality of life. While ketoconazole is being studied for its potential to reduce EGFR inhibitor-induced rash, other supportive treatments like topical steroids and antibiotics are commonly used to manage these skin toxicities.

What other types of research exist?

Promising alternatives to Ketoconazole for treating EGFR inhibitor-induced rash in cancer patients include topical corticosteroids, which can reduce inflammation and rash severity, and newer biologics like dupilumab, which targets specific pathways involved in skin inflammation. Additionally, other antifungal agents such as itraconazole and terbinafine may be considered, given their efficacy in treating fungal infections and potential to alleviate rash symptoms.

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Anti-fungal Agent

Ketoconazole for Cancer-related Rash

Q: What is the mechanism of action of this treatment?

Common cancer treatments include kinase inhibitors, immune checkpoint inhibitors, and traditional chemotherapy. Kinase inhibitors, such as temsirolimus and everolimus, target specific enzymes involved in cancer cell growth and survival, thereby inhibiting tumor progression. Immune checkpoint inhibitors, like anti-PD-1 and anti-CTLA-4 antibodies, enhance the body's immune response against cancer cells. Traditional chemotherapy, including agents like etoposide and cisplatin, works by damaging the DNA of rapidly dividing cells, leading to cell death. These treatments are crucial for cancer patients as they offer targeted approaches to control tumor growth, improve survival rates, and manage symptoms, thereby enhancing the overall quality of life. Additionally, managing side effects, such as EGFR inhibitor-induced rash with agents like ketoconazole, is essential for maintaining treatment adherence and patient comfort.

Phase < 1

Waitlist Available

Led By Aminah Jatoi

Research Sponsored by Mayo Clinic

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 up to 4 weeks

Awards & highlights

Study Summary

This trial is testing ketoconazole to see if it can help treat people with a specific kind of rash caused by EGFR inhibitor therapy.

Who is the study for?

This trial is for people with a rash or skin burning from EGFR inhibitor cancer treatment, who will continue this treatment for at least 28 days. Participants must be willing to complete quality-of-life questionnaires and may need to provide a skin biopsy. It's not open to those allergic to ketoconazole or sulfites.Check my eligibility

What is being tested?

The study tests if ketoconazole can ease rashes caused by EGFR inhibitors in cancer patients. It involves comparing the effects of ketoconazole against a placebo while monitoring participants' quality of life through questionnaires and lab biomarker analysis.See study design

What are the potential side effects?

Ketoconazole might cause side effects such as nausea, headache, dizziness, stomach pain, or changes in liver function tests. The severity varies among individuals.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 4 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 4 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Proportion of patients who report an improvement in skin rash

Secondary outcome measures

Incidence of adverse events for ketoconazole

Incidence of skin toxicity

Other outcome measures

Change in PLA2G4D, PLOD2, and SALL4

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (ketoconazole)Experimental Treatment4 Interventions

Participants apply ketoconazole topically BID on days 1-28.

Group II: Arm II (placebo)Placebo Group4 Interventions

Participants apply placebo topically BID on days 1-28.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ketoconazole

2011

Completed Phase 3

~1420

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common cancer treatments include kinase inhibitors, immune checkpoint inhibitors, and traditional chemotherapy. Kinase inhibitors, such as temsirolimus and everolimus, target specific enzymes involved in cancer cell growth and survival, thereby inhibiting tumor progression. Immune checkpoint inhibitors, like anti-PD-1 and anti-CTLA-4 antibodies, enhance the body's immune response against cancer cells. Traditional chemotherapy, including agents like etoposide and cisplatin, works by damaging the DNA of rapidly dividing cells, leading to cell death. These treatments are crucial for cancer patients as they offer targeted approaches to control tumor growth, improve survival rates, and manage symptoms, thereby enhancing the overall quality of life. Additionally, managing side effects, such as EGFR inhibitor-induced rash with agents like ketoconazole, is essential for maintaining treatment adherence and patient comfort.

Regorafenib-associated hand-foot skin reaction: practical advice on diagnosis, prevention, and management.Pharmacokinetics of oral neratinib during co-administration of ketoconazole in healthy subjects.Effect of ketoconazole on the pharmacokinetics of oral bosutinib in healthy subjects.

Find a Location

Who is running the clinical trial?

National Cancer Institute (NCI)NIH

13,717 Previous Clinical Trials

40,953,338 Total Patients Enrolled

Mayo ClinicLead Sponsor

3,239 Previous Clinical Trials

3,771,573 Total Patients Enrolled

Aminah JatoiPrincipal InvestigatorMayo Clinic

8 Previous Clinical Trials

236 Total Patients Enrolled

Media Library

Ketoconazole (Anti-fungal Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03471364 — Phase < 1

Cancer Research Study Groups: Arm I (ketoconazole), Arm II (placebo)

Cancer Clinical Trial 2023: Ketoconazole Highlights & Side Effects. Trial Name: NCT03471364 — Phase < 1

Ketoconazole (Anti-fungal Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03471364 — Phase < 1

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