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

Cyprus University of Technology

Status: Completed

Conditions: Breast Cancer; Colon Cancer; Consent Form; Pancreas Cancer; Lung Cancer; Head and Neck Cancer

Treatments: Other: Educational training program

Study type: Interventional

Funder types: Other

Identifiers

NCT03992664

0000-0001-5580-7256

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Experimental

Experimental group

Description:

The patients in the experimental group follow the educational program once weekly, for 4 weeks.

Treatment:

Other: Educational training program

NON-INTERVENTION

No Intervention group

Description:

The usual information was provided to them