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
- Conditions
- dermatological side effectsskin toxicities1002765510014982
- Registration Number
- NL-OMON39936
- Lead Sponsor
- Stichting IMPAQTT
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 120
* 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 <= 7 days before EGFRI treatment begins. EGFRI treatments: (e.g. panitumumab, cetuximab, lapatinib, gefitinib, and erlotinib).
* Have an Eastern Co-operative Oncology Group (ECOG) performance status <= 2.
* Ability to complete questionnaire(s) by themselves or with assistance.
* Patients need to be free of infection and not using any topical treatments on the skin.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>1. The incidence of grade >= 2 papulopustular eruption during the 6 week skin<br /><br>treatment within Bepanthen and Cetomacrogol, as measured by the CTCAE v4.0 and<br /><br>DERETT-H, an dermatologic specific healthcare provider questionnaire for<br /><br>Dermatological Reactions Targeted Therapy.<br /><br>2. Assess the impact of papulopustular eruptions on HRQoL as measured by the<br /><br>Functional Assessment of Cancer Therapy Questionnaire - EGFRI (FACT-EGFRI) and<br /><br>newly developed symptom experience diary Dermatological Reactions Targeted<br /><br>Therapy - Patients (DERETT-P).</p><br>
- Secondary Outcome Measures
Name Time Method <p>3. Determine the patient tolerability and satisfaction of Bepanthen®/<br /><br>Cetomacrogol cream as measured by DERETT-P.<br /><br>4. Determine the effectiveness of Bepanthen® cream versus Cetomacrogol cream on<br /><br>the adherence to anticancer agents as measured by FACT-EGFRI and DERETT-P.<br /><br>5. Assessments during the 6-week skin treatment period of the incidence and<br /><br>time to onset of other dermatological side effects which can appear together<br /><br>with papulopustular eruptions as measured by DERETT-H.</p><br>