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2019-01-01
2020-12-12
2022-08-10
40
NCT03992664
Cyprus University of Technology
Cyprus University of Technology
INTERVENTIONAL
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.
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.
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
| Study Registration Dates | Results Reporting Dates | Study Record Updates |
|---|---|---|
2019-06-15 | N/A | 2025-02-11 |
2019-06-19 | N/A | 2025-02-13 |
2019-06-20 | N/A | 2022-08 |
This section provides details of the study plan, including how the study is designed and what the study is measuring.
Primary Purpose:
Other
Allocation:
Randomized
Interventional Model:
Crossover
Masking:
Single
Arms and Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
| EXPERIMENTAL: Experimental The patients in the experimental group follow the educational program once weekly, for 4 weeks. | OTHER: Educational training program
|
| NO_INTERVENTION: NON-INTERVENTION The usual information was provided to them |
| Primary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Skin grades | Repeated measurements were taken weekly regarding the grade of rash, pruritus and photosensitivity. | 4 weeks |
| Secondary Outcome Measures | Measure Description | Time Frame |
|---|---|---|
| Functional health and wellbeing status | The SF-36 questionnaire (since week 0) and DLQI questionnaire (since week 1) were recorded. | 4 weeks |
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.
Ages Eligible for Study:
ALL
Sexes Eligible for Study:
18 Years
Accepts Healthy Volunteers:
This is where you will find people and organizations involved with this study.
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
No publications available
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The information and services provided by the National Pancreatic Cancer Foundation are for informational purposes only. The information and services are not intended to be substitutes for professional medical advice, diagnosis or treatment. The National Pancreatic Cancer Foundation does not recommend nor endorse any specific physicians, products or treatments even though they may be mentioned on this site.
