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

Breast Cancer Clinical Trial

— EGFR  

Official title:

Effectiveness of Educational Intervention for Patients That Receive Treatment With EGFRI

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03992664
• Other study ID #: 0000-0001-5580-7256
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: May 1, 2021

Study information

• Verified date: July 2020
• Source: Cyprus University of Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: May 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who take EGFR therapy for the first time.

• Classify at 0 or 1 according to WHO performance status.

Exclusion Criteria:

• Patients with previous exposure to EGFR treatment.

• People already suffering from rash.

• People already suffering with other dermatological problems, eg psoriasis.

• People already taking part in any other study.

Related Conditions & MeSH terms

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

Intervention

Other:
• EDUCATION
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.

Locations

Country	Name	City	State
Cyprus	Eleni Papoui	Larnaca	Athienou

Sponsors (1)

Lead Sponsor	Collaborator
Cyprus University of Technology

Country where clinical trial is conducted

Cyprus, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Through a randomized feasibility clinical trial to investigate the effectiveness of an educational intervention in conjunction with routine management of rash in patients receiving EGFRI therapy.	Identify the degree of rash using the NCI-CTCAE criteria. the degree of rash will compare in the experimental group (education) and in the non-experimental group (no education).	4 weeks
Secondary	Evaluation of the quality of life of all patients through the SF 36 questionnaire	The SF 36 questionnaire will be given to every patient from the first time of the meeting. The questionnaire will be given every week.	4 weeks
Secondary	Assessing the quality of life in relation to the rash through the QLQI questionnaire.	The QLQI questionnaire will be given in every patient from the second meeting because the questionnaire concerns questions about last week.	3 weeks