Cancer Clinical Trial
Official title:
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
Objective:
To assess the preemptive effect of Bepanthen® on decreasing the incidence of specific ≥ grade
2 dermatological side effects of interest in respect of compliance to EGFRI agents, HRQoL and
the adherence during the 6-week skin treatment period. The adherence to the study creams will
also be studied.
Rationale:
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.
Study design:
Multicenter, two-arm randomized, double blind, prospective parallel group design, phase III
study
Study population:
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.
Intervention:
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.
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