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

NCT ID: NCT01136005

Last Updated: 2017-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2017-03-31

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

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.

Conditions

Cancer; Skin Rash

Keywords

receptor, epidermal growth factor; skin reactions; quality of life; adherence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

dexpanthenol 5% cream

dexpanthenol 5% cream

Group Type: EXPERIMENTAL

dexpanthenol 5% cream

Intervention Type: OTHER

Apply at least two times a day on face, chest and upper arms during the 6 week treatment period

cetomacrogol cream

a vehicle

Group Type: ACTIVE_COMPARATOR

Cetomacrogol cream

Intervention Type: OTHER

Apply at least two times a day on face, chest and upper arms during the 6 week treatment period

Interventions

dexpanthenol 5% cream

Apply at least two times a day on face, chest and upper arms during the 6 week treatment period

Intervention Type: OTHER

Cetomacrogol cream

Apply at least two times a day on face, chest and upper arms during the 6 week treatment period

Intervention Type: OTHER

Other Intervention Names

Bepanthen; Provitamin

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CB Boers ORG

OTHER

Sponsor Role: collaborator

Memorial Sloan Kettering Cancer Center

OTHER

Sponsor Role: collaborator

Leiden University Medical Center

OTHER

Sponsor Role: collaborator

Bayer

INDUSTRY

Sponsor Role: collaborator

Impaqtt Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Christine Boers-Doets, MSc

Role: STUDY_CHAIR

Waterland Hospital, Purmerend, the Netherlands

Mario Lacouture, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial Sloan-Kettering Cancer Center, USA

Johan Nortier, PhD

Role: PRINCIPAL_INVESTIGATOR

Leiden University Medical Centre, the Netherlands

Locations

Medisch Centrum Alkmaar

Alkmaar, , Netherlands

Deventer ziekenhuis

Deventer, , Netherlands

Admiraal de Ruyter Hospital

Goes, , Netherlands

Leiden University Medical Centre

Leiden, , Netherlands

Waterland Hospital

Purmerend, , Netherlands

Zaans Medisch Centrum

Zaandam, , Netherlands

Countries

Netherlands

References

Clabbers JMK, Boers-Doets CB, Gelderblom H, Stijnen T, Lacouture ME, van der Hoeven KJM, Kaptein AA. Xerosis and pruritus as major EGFRI-associated adverse events. Support Care Cancer. 2016 Feb;24(2):513-521. doi: 10.1007/s00520-015-2781-y. Epub 2015 Jun 27.

Reference Type: DERIVED

PMID: 26111953 (View on PubMed)

Boers-Doets CB, Gelderblom H, Lacouture ME, Epstein JB, Nortier JW, Kaptein AA. Experiences with the FACT-EGFRI-18 instrument in EGFRI-associated mucocutaneous adverse events. Support Care Cancer. 2013 Jul;21(7):1919-26. doi: 10.1007/s00520-013-1752-4. Epub 2013 Feb 17.

Reference Type: DERIVED

PMID: 23417565 (View on PubMed)

Other Identifiers

M010-025

Identifier Type: OTHER

Identifier Source: secondary_id

Impaqtt-001

Identifier Type: -

Identifier Source: org_study_id