This phase II trial studies the side effect of triamcinolone in preventing rashes in cancer patients receiving EGFRI treatment. Triamcinolone 0.1% is a topical steroid used for the treatment of rashes caused by EGFRI treatment. EGFRI treatments specifically target areas in the body that are important for cancer cell growth and survival. Patients on EGFRI treatments most commonly experience rashes on the face, neck, chest and upper back area that are known as papulopustular eruption. These rashes caused by EGFRI have been known to give patients physical discomfort and psychological (mental) effects. The results of this study may help researchers to determine whether triamcinolone may lessen the amount or severity of EGFRI-associated rashes, improve patient quality of life, and whether it will increase the chance that patients can continue receiving cancer treatment.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03115567.
PRIMARY OBJECTIVE:
I. To assess the difference in percentage of participants who develop a grade 2 or greater rash in the control group as compared to the case group of preemptive treatment with topical steroids (triamcinolone acetonide [triamcinolone] 0.1% cream for application to face, chest and back) when administered concomitantly for 6 weeks with erlotinib, cetuximab, panitumumab, afatinib or osimertinib to prevent papulopustular eruptions.
SECONDARY OBJECTIVES:
I. To assess the difference in maximum severity of rash between the preemptive treatment group and the reactive treatment group.
II. To assess the difference in change in quality-of-life due to rash between the two treatment groups.
III. To determine whether there is a difference in adherence to chemotherapy between the two treatment groups.
IV. To determine if the results of baseline nasal swab cultures are associated with rash development or rash severity.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I (TREATMENT): Patients apply triamcinolone acetonide topically twice daily (BID) on the face, chest, and back for 6 weeks.
ARM II (CONTROL): Patients continue to apply skin moisturizer and sun protection before going outdoors daily for 6 weeks.
Trial PhasePhase II
Trial Typesupportive care
Lead OrganizationNorthwestern University
Principal InvestigatorJennifer Choi