dermatological side effects skin toxicities
Conditions
Interventions
80 patients will receive for the first 6 weeks of treatment Bepanthen crème, 80
patients Cetomacrogol crème to apply twice daily. Using FACT-EGFRI, a
dermatology-specific questionnaire, this study e
Sponsors
Stichting IMPAQTT
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Male and female subjects * >=18 years of age. * Patients must have signed an approved informed consent form prior to registration on study. * Histological proof of cancer. * A planned course of EGFRI treatment for any type of cancer. Patients must be entered on study
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will be excluded from the study: * Use of other concurrent topical creams or lotions at baseline. * Concomitant use of medications that may affect trial results (e.a. concurrent use of topical antibiotics, topical steroids, and other topical treatments on face and chest within 14 days of Day 0 (baseline); treatment with any systemic antibiotics within 7 days prior to Day 0. * Active dermatological conditions other than papulopustular eruption that may affect trial results. A skin examination reveals the presence of another skin disease in face or chest that may obscure rash to EGFRI and/or condition (excessive facial hair, excessive scarring, sunburn, or other disfigurement) located on the skin that, in the study physician's opinion, would confound the evaluation of the papulopustular eruption. * Known allergy or hypersensitivity to ingredients in Bepanthen® or Cetomacrogol. * Known sensitivity, papulopustular eruption or other abnormal skin reaction to topical or systemic medications or cleansing products at baseline. * Prior treatment with targeted therapy of any kind. * Current use of agents that are known to be strong inducers or inhibitors of CYP3A4 that can not be stopped.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. 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. 2. Assess the impact of papulopustular eruptions on HRQoL as measured by the Functional Assessment of Cancer Therapy Questionnaire - EGFRI (FACT-EGFRI) and newly developed symptom experience diary Dermatological Reactions Targeted Therapy - Patients (DERETT-P). | — |
Secondary
| Measure | Time frame |
|---|---|
| 3. Determine the patient tolerability and satisfaction of Bepanthen®/ Cetomacrogol cream as measured by DERETT-P. 4. Determine the effectiveness of Bepanthen® cream versus Cetomacrogol cream on the adherence to anticancer agents as measured by FACT-EGFRI and DERETT-P. 5. Assessments during the 6-week skin treatment period of the incidence and time to onset of other dermatological side effects which can appear together with papulopustular eruptions as measured by DERETT-H. | — |
Countries
Netherlands
Outcome results
None listed