NCT03992664

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Cyprus University of Technology · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Consent Form
• Lung Cancer
• Colon Cancer
• Pancreas Cancer
• Head and Neck Cancer
• Breast Cancer

Interventions

Type	Name	Description
OTHER	Educational training program	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.

Timeline

• Start date: 2019-01-01
• Primary completion: 2020-12-12
• Completion: 2022-08-10
• First posted: 2019-06-20
• Last updated: 2025-02-13

Locations

1 site across 1 country: Cyprus