Consent FormNCT03992664
Education Intervention in Patients with Rash Due to Epidermal Growth Factor Receptor (EGFR) Treatment.
A study testing Educational training program in people with Consent Form and Lung Cancer, run by Cyprus University of Technology at 1 site in Cyprus.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Consent Form, Lung Cancer, Colon Cancer
- What is being tested?
- Educational training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCyprus
- Study dates
- 1 Jan 2019to 10 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Adult cancer patients (>18).
- Patients who suffered with pruritus, or rash or photosensitivity, in the onset of the symptoms.
- Willing to participate.
- Ability to complete the questionnaires.
- A performance status of two or less on the Eastern Cooperative Oncology Group (ECOG).
- Patients with no pre-existing dermatological condition that may limit the interpretation of results.
Trial locations and contacts
1 site in 1 country.
About this study
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.
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.
Read more
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.
Read the 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.
- Conditions
- Consent Form, Lung Cancer, Colon Cancer, Pancreas Cancer, Head and Neck Cancer, Breast Cancer
- Being tested
- Educational training program
- Keywords
- rash, photosensitivity, pruritus, educational, chemotherapy, EGFRI, immunotherapy
- Medical subject headings
- Lung Neoplasms, Colonic Neoplasms, Pancreatic Neoplasms, Head and Neck Neoplasms, Breast Neoplasms, Exanthema, Photosensitivity Disorders, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational training programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | The patients in the experimental group follow the educational program once weekly, for 4 weeks. Receives: Other: Educational training program |
| NON-INTERVENTION | No intervention | The usual information was provided to them |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin grades
Repeated measurements were taken weekly regarding the grade of rash, pruritus and photosensitivity.
Measured: 4 weeks
Secondary outcomes (1)
Functional health and wellbeing status
The SF-36 questionnaire (since week 0) and DLQI questionnaire (since week 1) were recorded.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2019
- Study start1 Jan 2019
- Primary completion12 Dec 2020
- Study completion10 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Consent FormStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cyprus University of Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ELENI PAPOUI, Cyprus University of Technology
- Investigators
- ANDREAS CHARALAMBOUS, PhD, Study director, Cyprus University of Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03992664
- Sponsor's protocol ID
- 0000-0001-5580-7256
- Status last verified
- Aug 2022
- First submitted
- 15 Jun 2019
- Last updated
- 13 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT03992664
- Acronym / sponsor ID
- 0000-0001-5580-7256
- Conditions
- Consent Form, Lung Cancer, Colon Cancer, Pancreas Cancer, Head and Neck Cancer, Breast Cancer
- Keywords
- rash, photosensitivity, pruritus, educational, chemotherapy, EGFRI, immunotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cyprus University of TechnologyUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 10 Aug 2022 (actual)
- First posted
- 20 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: Educational training programThe 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational training programThe 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. | Other | Experimental |
Primary outcome
Skin grades
Time frame: 4 weeks
Repeated measurements were taken weekly regarding the grade of rash, pruritus and photosensitivity.
1 secondary outcome
Functional health and wellbeing status
Time frame: 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ANDREAS CHARALAMBOUS, PhD study director
Cyprus University of Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational training program in people with Consent Form and Lung Cancer, run by Cyprus University of Technology at 1 site in Cyprus.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Cyprus. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin grades (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2025; AzTrials last refreshed its copy on 7 Nov 2026.