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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Educational training program | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Skin grades | Repeated measurements were taken weekly regarding the grade of rash, pruritus and photosensitivity. | 4 weeks |
| 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 |
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| Name | Affiliation | Role |
|---|---|---|
| ANDREAS CHARALAMBOUS, PhD | Cyprus University of Technology | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eleni Papoui | Larnaca | ATHIENOU | 7600 | Cyprus |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D003110 | Colonic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D001943 | Breast Neoplasms |
| D005076 | Exanthema |
| D010787 | Photosensitivity Disorders |
| D011537 | Pruritus |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |