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Education Intervention in Patients With Rash Due to Epidermal Growth Factor Receptor (EGFR) Treatment. (EGFR)
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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Consent Form Lung Cancer Colon Cancer Pancreas Cancer Head and Neck Cancer Breast Cancer | Other: EDUCATION | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 40 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Single (Participant) |
| Primary Purpose: | Treatment |
| Official Title: | Effectiveness of Educational Intervention for Patients That Receive Treatment With EGFRI |
| Actual Study Start Date : | January 1, 2019 |
| Estimated Primary Completion Date : | January 1, 2021 |
| Estimated Study Completion Date : | May 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: EDUCATION
If the patient is in the experimental team, questionnaires and printed education information will be given first and after the completion of the forms, the intervention will be followed.
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Other: EDUCATION
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. Other Name: TRAINING PRAGRAMM
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No Intervention: NON-INTERVENTION
The difference in this group is that it will not be explained or given a form of educational intervention for management of rash.
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- Through a randomized feasibility clinical trial to investigate the effectiveness of an educational intervention in conjunction with routine management of rash in patients receiving EGFRI therapy. [ Time Frame: 4 weeks ]Identify the degree of rash using the NCI-CTCAE criteria. the degree of rash will compare in the experimental group (education) and in the non-experimental group (no education).
- Evaluation of the quality of life of all patients through the SF 36 questionnaire [ Time Frame: 4 weeks ]The SF 36 questionnaire will be given to every patient from the first time of the meeting. The questionnaire will be given every week.
- Assessing the quality of life in relation to the rash through the QLQI questionnaire. [ Time Frame: 3 weeks ]The QLQI questionnaire will be given in every patient from the second meeting because the questionnaire concerns questions about last week.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients who take EGFR therapy for the first time.
- Classify at 0 or 1 according to WHO performance status.
Exclusion Criteria:
- Patients with previous exposure to EGFR treatment.
- People already suffering from rash.
- People already suffering with other dermatological problems, eg psoriasis.
- People already taking part in any other study.
| Cyprus | |
| Eleni Papoui | |
| Larnaca, Athienou, Cyprus, 7600 | |
| Study Director: | ANDREAS CHARALAMBOUS, PhD | Cyprus University of Technology |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date ICMJE | June 15, 2019 | ||||
| First Posted Date ICMJE | June 20, 2019 | ||||
| Last Update Posted Date | July 30, 2020 | ||||
| Actual Study Start Date ICMJE | January 1, 2019 | ||||
| Estimated Primary Completion Date | January 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Through a randomized feasibility clinical trial to investigate the effectiveness of an educational intervention in conjunction with routine management of rash in patients receiving EGFRI therapy. [ Time Frame: 4 weeks ] Identify the degree of rash using the NCI-CTCAE criteria. the degree of rash will compare in the experimental group (education) and in the non-experimental group (no education).
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | |||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Education Intervention in Patients With Rash Due to Epidermal Growth Factor Receptor (EGFR) Treatment. | ||||
| Official Title ICMJE | Effectiveness of Educational Intervention for Patients That Receive Treatment With EGFRI | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase ICMJE | Not Applicable | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single (Participant) Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | Other: EDUCATION
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. Other Name: TRAINING PRAGRAMM
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE |
40 | ||||
| Original Estimated Enrollment ICMJE | Same as current | ||||
| Estimated Study Completion Date ICMJE | May 1, 2021 | ||||
| Estimated Primary Completion Date | January 1, 2021 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers ICMJE | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries ICMJE | Cyprus | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT03992664 | ||||
| Other Study ID Numbers ICMJE | 0000-0001-5580-7256 | ||||
| Has Data Monitoring Committee | Yes | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | ELENI PAPOUI, Cyprus University of Technology | ||||
| Study Sponsor ICMJE | Cyprus University of Technology | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| PRS Account | Cyprus University of Technology | ||||
| Verification Date | July 2020 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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