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

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Waterland Hospital
Sponsor:
Collaborator:
Bayer
Information provided by (Responsible Party):
Christine B Boers-Doets, Waterland Hospital
ClinicalTrials.gov Identifier:
NCT01136005
First received: June 2, 2010
Last updated: June 11, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Cancer
Skin Rash
Other: cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Waterland Hospital:

Primary Outcome Measures:
  • grade 2 or more papulopustular eruption [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • impact of papulopustular eruptions on HRQoL [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • patient tolerability and satisfaction of study cream [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Determine the patient tolerability and satisfaction of Bepanthen®/ Cetomacrogol cream as measured by DERETT-P.

  • effectiveness of study cream on the adherence [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Determine the effectiveness of Bepanthen® cream versus Cetomacrogol cream on the adherence to anticancer agents as measured by FACT-EGFRI and DERETT-P.

  • other dermatological side effects [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 160
Study Start Date: September 2010
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: dexpanthenol 5% cream
dexpanthenol 5% cream (Bepanthen)
Other: cream
apply at least two times a day on face, chest and upper arms during the 6 week treatment period
Other Names:
  • Bepanthen
  • Cetomacrogol
Active Comparator: cetomacrogol cream
a vehicle
Other: cream
apply at least two times a day on face, chest and upper arms during the 6 week treatment period
Other Names:
  • Bepanthen
  • Cetomacrogol

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 ≤ 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 Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01136005

Contacts
Contact: Christine B Boers-Doets, MSc +31-6-24790618 C.B.Boers-Doets@lumc.nl
Contact: Mario E Lacouture, MD +1-212 -610-0079 lacoutum@mskcc.org

Locations
Netherlands
Medisch Centrum Alkmaar Recruiting
Alkmaar, Netherlands, 1815 JD
Contact: Carolien H Smorenburg, PhD    +31-72-5482804    c.h.smorenburg@mca.nl   
Contact: Manon Komen, MSc    +31-72-5482872    M.Komen@mca.nl   
Principal Investigator: Carolien H Smorenburg, PhD         
Deventer ziekenhuis Recruiting
Deventer, Netherlands, 7400 GC
Contact: A LT Imholz         
Contact: Erika ten Berge-Groen, RN    0031-570-536437    e.tenBerge@dz.nl   
Principal Investigator: A LT Imholz         
Admiraal de Ruyter Hospital Recruiting
Goes, Netherlands, 4460 BB
Contact: Annemie FS Galimont, MD    +31-113-234655    a.galimont@adrz.nl   
Contact: Suzan van Spijk, RN    +31-113-234510    s.vanspijk@adrz.nl   
Principal Investigator: Annemie Galimont, MD, PhD         
Leiden University Medical Centre Recruiting
Leiden, Netherlands, 2333 ZA
Contact: Johan WR Nortier, PhD    0031-71-5264912    j.w.r.nortier@lumc.nl   
Contact: Jan Ouwerkerk, RN    0031-71-5261965    J.Ouwerkerk@lumc.nl   
Principal Investigator: Johan WR Nortier, PhD, prof         
Waterland Hospital Recruiting
Purmerend, Netherlands, 1440AG
Contact: Christine B Boers-Doets, MSc    0031-6-24790618    C.B.Boers-Doets@lumc.nl   
Contact: Jan AC Brakenhoff, MD    0031-299-457457    Brakenhoff@wlz.nl   
Principal Investigator: Jan AC Brakenhoff, MD         
Zaans Medisch Centrum Recruiting
Zaandam, Netherlands, 1500 EE
Contact: Aart van Bochove, MD    +31-75-6507211    bochove.a@zaansmc.nl   
Contact: Marianne de Waard, RN    0031-75-6507280    Waard.m@zaansmc.nl   
Principal Investigator: Aart van Bochove         
Sponsors and Collaborators
Christine B Boers-Doets
Bayer
Investigators
Study Chair: Christine Boers-Doets, MSc Waterland Hospital, Purmerend, the Netherlands
Principal Investigator: Mario Lacouture, MD Memorial Sloan-Kettering Cancer Center, USA
Principal Investigator: Johan Nortier, PhD Leiden University Medical Centre, the Netherlands
  More Information

No publications provided by Waterland Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Christine B Boers-Doets, MSc, RN, Waterland Hospital
ClinicalTrials.gov Identifier: NCT01136005     History of Changes
Other Study ID Numbers: Esperanz-001, M010-025
Study First Received: June 2, 2010
Last Updated: June 11, 2013
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Waterland Hospital:
receptor, epidermal growth factor
skin toxicity
quality of life
adherence

Additional relevant MeSH terms:
Mitogens
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 01, 2014