This phase II trial tests how well topical tretinoin works for the prevention of anti-EGFR therapy-induced skin toxicity in patients undergoing treatment for colorectal cancer that has spread from where it first started (primary site) to other places in the body (metastatic). A common side effect of anti-EGFR treatment is a papulopustular acneiform rash that can significantly impact a patient’s quality of life. Tretinoin, also called all-trans retinoic acid, is in a class of medications called retinoids. All-trans retinoic acid is made in the body from vitamin A and helps cells to grow and develop. A form of all-trans retinoic acid made in the laboratory can be used on the skin to treat conditions such as acne. Topical tretinoin may prevent or reduce the development of an acneiform rash among patients receiving anti-EGFR treatment for metastatic colorectal cancer.
Additional locations may be listed on ClinicalTrials.gov for NCT06358677.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Active
Contact: Christopher Duane Nevala-Plagemann
Phone: 801-585-0255
PRIMARY OBJECTIVE:
I. To measure the effect of topical tretinoin on anti-EGFR induced acneiform rash.
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of topical tretinoin in the study population.
II. Proportion of acneiform rash per Common Terminology Critieria for Adverse Events (CTCAE) version (v) 5.0.
EXPLORATORY OBJECTIVE:
I. To measure the effect of topical tretinoin on anti-EGFR treatment-induced facial rash after 4 weeks of bilateral treatment.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients apply tretinoin to the left side of their face and Eucerin cream moisturizer to the right side of their face once per day for up to 6 weeks in the absence of unacceptable toxicity while receiving standard of care anti-EGFR therapy. At the discretion of the investigator, patients may then apply tretinoin once per day on both sides of their face for up to 4 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the trial.
ARM II: Patients apply tretinoin to the right side of their face and Eucerin cream moisturizer to the left side of their face once per day for up to 6 weeks in the absence of unacceptable toxicity while receiving standard of care anti-EGFR therapy. At the discretion of the investigator, patients may then apply tretinoin once per day on both sides of their face for up to 4 weeks in the absence of unacceptable toxicity. Patients undergo blood sample collection throughout the trial.
After completion of study treatment, patients are followed up at 30 days.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorChristopher Duane Nevala-Plagemann
