Bepanthen Versus Cetomacrogol in Epidermal Growth Factor Receptor Inhibitors (EGFRI)

Last updated: November 8, 2017
Sponsor: Impaqtt Foundation
Overall Status: Completed

Phase

3

Condition

Molluscum Contagiosum (Pediatric)

Hives (Urticaria)

Smallpox

Treatment

N/A

Clinical Study ID

NCT01136005
Impaqtt-001
M010-025
  • Ages > 18
  • All Genders

Study 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 the adherence during the 6-week skin treatment period. The adherence to the study creams will also be studied.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Male and female subjects

  • ≥18 years of age.

  • Patients must have signed an approved informed consent form prior to registration onstudy.

  • Histological proof of cancer.

  • A planned course of EGFRI treatment for any type of cancer. Patients must be enteredon 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 theskin.

Exclusion

Exclusion Criteria:

  • Use of other concurrent topical creams or lotions at baseline.

  • Concomitant use of medications that may affect trial results (e.a. concurrent use oftopical antibiotics, topical steroids, and other topical treatments on face and chestwithin 14 days of Day 0 (baseline); treatment with any systemic antibiotics within 7days prior to Day 0.

  • Active dermatological conditions other than papulopustular eruption that may affecttrial results. A skin examination reveals the presence of another skin disease in faceor 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 thestudy physician's opinion, would confound the evaluation of the papulopustulareruption.

  • Known allergy or hypersensitivity to ingredients in Bepanthen® or Cetomacrogol.

  • Known sensitivity, papulopustular eruption or other abnormal skin reaction to topicalor 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 CYP3A4that can not be stopped

Study Design

Total Participants: 160
Study Start date:
September 01, 2010
Estimated Completion Date:
March 31, 2017

Study 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 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.

Connect with a study center

  • Medisch Centrum Alkmaar

    Alkmaar, 1815 JD
    Netherlands

    Site Not Available

  • Deventer ziekenhuis

    Deventer, 7400 GC
    Netherlands

    Site Not Available

  • Admiraal de Ruyter Hospital

    Goes, 4460 BB
    Netherlands

    Site Not Available

  • Leiden University Medical Centre

    Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Waterland Hospital

    Purmerend, 1440AG
    Netherlands

    Site Not Available

  • Zaans Medisch Centrum

    Zaandam, 1500 EE
    Netherlands

    Site Not Available

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