Phase III Randomized Double-Blind Trial of Bepanthen® Cream Versus Cetomacrogol Cream in the Prevention of Papulopustular Eruption in Patients Receiving Epidermal Growth Factor Receptor Inhibitors (EGFRI): BeCet
Dermatological side effects, such as papulopustular eruption, xerosis, pruritus, periungual
inflammation, mucosal-, and hair abnormalities, and edema occur in up to 90% of patients
during treatment with epidermal growth factor receptor inhibitors (EGFRI). Patients are
hindered in their daily activities and cannot maintain privacy about their illness because
of the prominent side effects. The aesthetic discomfort, which is frequently associated with
itching or painful skin or nails can lead to a decreased health related quality of life
(HRQoL) and to dose reduction or discontinuation of anticancer treatment.
Patients with dermatological side effects have also an increased risk for cutaneous
infections (at least 38%) which can complicate dermatological side effects.
At present, evidence of the effectiveness of the management options for dermatological side
effects is lacking, and the effect of the dermatological side effects on HRQoL and adherence
remains poorly understood.
Dexpanthenol cream (Bepanthen®, Bayer) has been used extensively to ameliorate acute
radiation induced skin toxicity, diaper dermatitis, irritant hand dermatitis, graft-donor
site wound healing and burn patients. The hypothesis is that its skin healing possibilities
decreases this kind of side effects.
Multicenter, two-arm randomized, double blind, prospective parallel group design, phase III
Each patient starting for the first time with EGFRI anticancer therapy which can cause
papulopustular eruption (cetuximab, panitumumab, erlotinib, gefitinib, lapatinib, or other),
will be included.
80 patients will receive for the first 6 weeks of treatment Bepanthen cream, 80 patients
Cetomacrogol cream to apply twice daily. Using FACT-EGFRI, a dermatology-specific
questionnaire, this study examines the effect of these side effects on three domains of
HRQoL - symptoms, emotions, and functioning. Severity of dermatological side effects will be
assessed using the NCI-CTCAE v4.0. Correlation of dermatology HRQoL scores with NCI-CTCAE
grade, sex, age, type of EGFRI, and cancer type will be conducted.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
grade 2 or more papulopustular eruption
The incidence of grade ≥ 2 papulopustular eruption during the 6 week skin treatment within Bepanthen and Cetomacrogol, as measured by the CTCAE v4.0 and DERETT-H, an dermatologic specific healthcare provider questionnaire for Dermatological Reactions Targeted Therapy.
Christine Boers-Doets, MSc
Waterland Hospital, Purmerend, the Netherlands
Netherlands: Medical Ethics Review Committee (METC)