Breast Cancer, Colon Cancer, Consent Form, Head and Neck Cancer, Lung Cancer, Pancreas Cancer
Conditions
Keywords
rash, photosensitivity, pruritus, educational, chemotherapy, EGFRI, immunotherapy
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.
Interventions
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.
Sponsors
Cyprus University of Technology
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin grades | 4 weeks | Repeated measurements were taken weekly regarding the grade of rash, pruritus and photosensitivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional health and wellbeing status | 4 weeks | The SF-36 questionnaire (since week 0) and DLQI questionnaire (since week 1) were recorded. |
Countries
Cyprus
Outcome results
None listed