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

NCT01136005 | Completed Phase 3

• 2 other identifiers: Impaqtt-001M010-025
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 6

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.

Conditions

Cancer; Skin Rash

Keywords

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

Outcome Measures

Primary Outcomes (2)

• grade 2 or more papulopustular eruption

  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.

  6 weeks

• impact of papulopustular eruptions on HRQoL

  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).

  6 weeks

Secondary Outcomes (3)

• patient tolerability and satisfaction of study cream

  6 weeks

• effectiveness of study cream on the adherence

  6 weeks

• other dermatological side effects

  6 weeks

Study Arms (2)

dexpanthenol 5% cream

EXPERIMENTAL

dexpanthenol 5% cream

Other: dexpanthenol 5% cream

cetomacrogol cream

ACTIVE COMPARATOR

a vehicle

Other: Cetomacrogol cream

Interventions

dexpanthenol 5% cream OTHER

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

Also known as: Bepanthen, Provitamin

dexpanthenol 5% cream

Cetomacrogol cream OTHER

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

cetomacrogol cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Impaqtt Foundation: lead
• CB Boers ORG: collaborator
• Memorial Sloan Kettering Cancer Center: collaborator
• Leiden University Medical Center: collaborator
• Bayer: collaborator

Study Sites (6)

Medisch Centrum Alkmaar

Alkmaar, 1815 JD, Netherlands

Location

Deventer ziekenhuis

Deventer, 7400 GC, Netherlands

Location

Admiraal de Ruyter Hospital

Goes, 4460 BB, Netherlands

Location

Leiden University Medical Centre

Leiden, 2333 ZA, Netherlands

Location

Waterland Hospital

Purmerend, 1440AG, Netherlands

Location

Zaans Medisch Centrum

Zaandam, 1500 EE, Netherlands

Location

Related Publications (2)

• 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.

  PMID: 26111953 DERIVED

• 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.

  PMID: 23417565 DERIVED

MeSH Terms

Conditions

Neoplasms; Exanthema

Interventions

dexpanthenol; Provitamins

Condition Hierarchy (Ancestors)

Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vitamins; Micronutrients; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Nutrients; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Christine Boers-Doets, MSc

  Waterland Hospital, Purmerend, the Netherlands

  STUDY CHAIR

• Mario Lacouture, MD

  Memorial Sloan-Kettering Cancer Center, USA

  PRINCIPAL INVESTIGATOR

• Johan Nortier, PhD

  Leiden University Medical Centre, the Netherlands

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2010
• First Posted: June 3, 2010
• Study Start: September 1, 2010
• Primary Completion: December 1, 2016
• Study Completion: March 1, 2017
• Last Updated: November 13, 2017

Record last verified: 2017-11

Locations

NL (6)