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.
| Registry | NCT03992664 |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, crossover, masking: single, other |
| Enrollment | 40 (Actual) |
| Sponsor | Cyprus University of Technology (Other) |
| Conditions | Consent Form, Lung Cancer, Colon Cancer, Pancreas Cancer, Head and Neck Cancer, Breast Cancer |
| Interventions | Educational training program (Other) |
| Dates | start 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 in Cyprus |
Related Papers Related Patents Related Grants Related Experts
AI Assistant Save
All trials for Consent Form All trials for Lung Cancer All trials of Educational training program
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Experimental | Experimental | Other: Educational training program | The patients in the experimental group follow the educational program once weekly, for 4 weeks. |
| NON-INTERVENTION | No intervention | The usual information was provided to them |
Sex: All, ages: 18 Years to any
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.
| Facility | City | Country | Status |
|---|---|---|---|
| Eleni Papoui | Larnaca, ATHIENOU | Cyprus |