Skip to main content
OpenTrials
Completed

NCT Number: NCT03992664

Education Intervention in Patients with Rash Due to Epidermal Growth Factor Receptor (EGFR) Treatment.

The main adverse reaction of EGFR seen in patients is rash. EGFR treated patients have a 24-95% incidence of rash depending on the type of treatment they receive. Skin toxicity may occur in more than 80% of patients treated with cetuximab.

If a severe rash (Grade 3 or 4) occurs, a dose reduction or discontinuation of treatment may be required. Also, infections are the main secondary side effect caused by the rash.

The aim of the study is through a randomized clinical trial feasibility study to investigate the effectiveness of an educational intervention in patients receiving EGFRI therapy.

It will be randomly selected which patients will belong to the intervention group and who in the control group. The type of program involves educational intervention.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Consent Form Breast Cancer Breast Diseases Breast Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Exanthema Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Pancreas Cancer Pancreatic Diseases Pancreatic Neoplasms Pathological Conditions, Signs and Symptoms Photosensitivity Disorders Pruritus Respiratory Tract Diseases Respiratory Tract Neoplasms Signs and Symptoms Skin Diseases Skin Manifestations Skin and Connective Tissue Diseases Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Eleni Papoui

Larnaca, ATHIENOU, 7600, Cyprus

About this study

In recent years, EGFRI (Epidermal Growth Factor Receptor Inhibitor) have evolved as effective anti-cancer drugs. They are distinguished in monoclonal antibodies (cetuximab and panitumumab) and EGFR (TKIs) kinase inhibitors gefitinib, erlotinib and lapatinib, where they are used in the treatment of colon, rectal, head and neck, lung, pancreas and of breast.

According to studies, the usual treatment for the prevention and treatment of skin rash refers to the use of antibiotics such as doxycycline, tetracycline and cortisone products such as hydrocortisone. It is also recommended to use moisturizing cream.

The study of Carmine P. et al., 2011 mentions the need to investigate educational measures for the rash due to EGFR treatment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • Adult cancer patients (>18).
  • Patients who suffered with pruritus, or rash or photosensitivity, in the onset of the symptoms.
  • Willing to participate.
  • Ability to complete the questionnaires.
  • A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG).
  • Patients with no pre-existing dermatological condition that may limit the interpretation of results.

Treatment and study plan

Educational training program

Other

The training program will focus on four parameters: cleanliness, hydration, protection from external stimuli, and finally early detection of skin side effects.

The re-evaluation of the skin as well as the repetition of the questionnaires will be done every week for 4 weeks.

Primary outcomes

  1. Skin grades

    Time frame: 4 weeks

    Repeated measurements were taken weekly regarding the grade of rash, pruritus and photosensitivity.

Secondary outcomes

  1. Functional health and wellbeing status

    Time frame: 4 weeks

    The SF-36 questionnaire (since week 0) and DLQI questionnaire (since week 1) were recorded.

Sponsors and collaborators

Lead sponsor

Cyprus University of Technology

Other

Registry information

Official study title

A Pilot Randomized Controlled Study on the Effects of an Educational Training Program on Skin Reactions Induced by Chemotherapies, Epidermal Growth Factor Inhibitors (EGFRI) Treatments, and Immunotherapies.

Important dates

Study start
2019
Primary completion
2020
Study completion
2022
First posted
Jun 20, 2019
Registry last updated
Feb 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.