Clinical trial NCT03992664: Education Intervention in Patients with Rash Due to Epidermal Growth Factor Receptor (EGFR) Treatment.
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Consent Form
Lung Cancer
Colon Cancer
Pancreas Cancer
Head and Neck Cancer
Breast Cancer
Keywords: rash, photosensitivity, pruritus, educational, chemotherapy, EGFRI, immunotherapy
Lead sponsor: Cyprus University of Technology
Sponsor class: OTHER
First posted: 2019-06-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Skin grades
timeFrame: 4 weeks
Secondary outcomes:
measure: Functional health and wellbeing status
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Larnaca
country: Cyprus
facility: Eleni Papoui
state: Athienou
Study officials:
affiliation: Cyprus University of Technology
name: ANDREAS CHARALAMBOUS, PhD
role: STUDY_DIRECTOR
References: