Status:
COMPLETED
Bepanthen Versus Cetomacrogol in Epidermal Growth Factor Receptor Inhibitors (EGFRI)
Lead Sponsor:
Impaqtt Foundation
Collaborating Sponsors:
CB Boers ORG
Memorial Sloan Kettering Cancer Center
Conditions:
Cancer
Skin Rash
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 ...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2017
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT01136005
Start Date
September 1 2010
End Date
March 1 2017
Last Update
November 13 2017
Active Locations (6)
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1
Medisch Centrum Alkmaar
Alkmaar, Netherlands, 1815 JD
2
Deventer ziekenhuis
Deventer, Netherlands, 7400 GC
3
Admiraal de Ruyter Hospital
Goes, Netherlands, 4460 BB
4
Leiden University Medical Centre
Leiden, Netherlands, 2333 ZA