Head and Neck Squamous Cell CarcinomaCICAFIXNCT03421912
Satisfaction and Quality of Life Comparison Between Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGFR)
A study testing Cicaplast Balm B5 and Dexeryl in people with Head and Neck Squamous Cell Carcinoma and Colorectal Cancer, run by Centre Leon Berard at 1 site in France.
Trial summary
This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Non Small Cell Lung Cancer
- What is being tested?
- Cicaplast Balm B5 and Dexeryl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2018to 11 May 2021
- 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
Who may be able to join
- Age ≥ 18 years.
- Patient with recurrent and / or metastatic head and neck squamous cell carcinoma OR metastatic colorectal cancer with non-mutated RAS gene (wild-type) OR non-small cell lung cancer (NSCLC) with EGFR activating mutations.
- Treated for the first time by an iEGFR having received a marketing authorization.
- Having signed a consent to participate in the study.
- Affiliated to a health insurance plan (or beneficiary of such a plan).
Who cannot join
- Concomitant radiotherapy.
- Unresolved skin toxicity from previous treatment, whatever it may be.
- Concomitant use of other topical treatments.
- Known hypersensitivity to at least one of the components of the topicals used.
- Pregnant or lactating women.
- Participation in another clinical trial (even if supportive care)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Monocentric Randomized Study Evaluating the Satisfaction and Quality of Life of Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGRF) in Carcinomas Squamous Cells of the Head and Neck, Colorectal Cancers or Lung Cancers
This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary
Read the detailed description
The arrival of new therapeutic strategies such as targeted therapies has led to real progress in the treatment of cancers. Tyrosine kinase inhibitors and antibodies to epidermal growth factor receptors (EGFR), or iEGFR, target one of the major pathways of tumor cell proliferation. These treatments have demonstrated their interest in the treatment of certain advanced solid malignant tumors (head and neck cancer, colorectal cancer, bronchial cancer).
Although having a much better tolerance profile than the "classical" cytotoxic treatments used in the same indications, these treatments, however, have frequent cutaneous toxicities that are inconvenient for patients. According to the molecules, they can affect 80 to 90% of patients treated from the first weeks of treatment and to different degrees. They appear as well in the skin (acneiform rash, erythema, desquamation, xerosis, pruritus) as skin appendages (paronychia, alopecia).
The consequences of these adverse effects are significant, which may be at the origin of a decrease in dose or even of a stop of anti-tumoral treatment inducing a reduction of the expected clinical benefit. In addition, they represent for the patient a real source of inconvenience and pain, which can impact the quality of life (choice of dress, feeling of shame because of the appearance of the skin ...) and impact the adherence to iEGFR treatment.
Management includes first and foremost preventive measures: the use of moisturizing topicals and dermatological soap-free surgras is recommended as soon as iEGFR treatment is initiated, and preventive systemic treatment with cyclins (doxycycline 100 mg daily) is proposed for at least 6 weeks and then reevaluated for skin toxicity.
In case of appearance of skin toxicities, it is initially prescribed in common practice a topical such as Dexeryl (used in many hospitals as standard) or Cicaplast Balm B5 La Roche Posay (used in current practice at Léon Bérard Center). In a second step, topical corticosteroids are prescribed, depending on the grade of toxicity.
There is, however, no validated argument in the literature to guide the choice of clinicians to use either of these topics. Cicaplast balm B5 (antibacterial, repairing damaged skin, moisturizing and relieving feelings of discomfort) would limit the aggravation of skin toxicities and therefore the use of pharmacological measures, including topical corticosteroids class 3 or 4 may long term, weaken the skin barrier even more.
This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary
- Conditions
- Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Non Small Cell Lung Cancer, Epidermal Growth Factor Receptor Inhibitor
- Being tested
- Cicaplast Balm B5, Dexeryl
- Keywords
- Prevention strategy, Cutaneous toxicity, Quality of life, Patient satisfaction, Dermatology Life Quality Index (DLQI), Epidermal Repair Score (SCOREPI), Topical treatment
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck, Colorectal Neoplasms, Carcinoma, Non-Small-Cell Lung, Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cicaplast Balm B5Other
The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers
DexerylOther
The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers
| Study group | Role | What they receive |
|---|---|---|
| Arm A : Cicaplast balm B5 | Experimental | Use of Cicaplast balm B5, 2 to 3 applications per day, since the first day of iEGFR treatment initiation for 30 days to avoid or limit appearance of cutaneous toxicities related to iEGFR treatment. Receives: Other: Cicaplast Balm B5 |
| Arm B : Dexeryl | Active comparator | Use of Dexeryl, 2 to 3 applications per day, since de first day of iEGFR treatment initiation for 30 days to avoid or limit appearence of cutaneous toxicities related to iEGFR treatment. Receives: Other: Dexeryl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall patient satisfaction after 30 days treatment
Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm
Measured: After 30 days of treatment or at the end of treatment for patient who interrupt the treatment before 30 days
Secondary outcomes (8)
Overall patient satisfaction after 60 days treatment
Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm
Measured: After 60 days of treatment or at the end of treatment for patient who interrupt the treatment before 60 days
Patient Quality of life
Quality of life of patient will be evaluated by using the Dermatology Life Quality Index questionnaire (DLQI) in each arm
Measured: At inclusion, after 30 and 60 days of treatment
Cutaneous toxicities evaluation using Epidermal Repair Score (SCOREPI)
Cutaneous toxicities will be evaluated in each arm by using Epidermal Repair Score (SCOREPI)
Measured: After 15, 30 and 60 days of treatment
Cutaneous toxicities evaluation using Common Terminology Criteria for Adverse Events (CTCAE) version 4
Cutaneous toxicities will be evaluated in each arm by using Common Terminology Criteria for Adverse Events (CTCAE) version 4
Measured: After 15, 30 and 60 days of treatment
Modification/Interruption/Discontinuing iEGFR treatment rate
Modification/Interruption/Discontinuing iEGFR treatment rate in each arm because of cutaneous toxicity
Measured: Continuously up to 30 days after starting treatment
DLQI and SCOREPI scores correlation
Evaluation of DLQI (patient evaluation) and SCOREPI (investigator evaluation) scores correlation in each arm
Measured: After 30 and 60 days of treatment
Topical observance
Topical observance will be evaluated in each arm by data collection by each patient in a diary
Measured: Between the 1st day and the 15th day of treatment, and between the 15th and the 30th day of treatment
Use rate of dermocorticoids
Evaluation of the rate of patients needing to use dermocorticoids.
Measured: Continously up to 60 days after starting treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2018
- Study start16 Feb 2018
- Primary completion11 Apr 2021
- Study completion11 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Squamous Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Arm A : Use of Cicaplast balm B5 since de first day of iEGFR initiation treatment for 30 days Arm B : Use of Dexeryl cream since de first day of iEGFR initiation treatment for 30 days
- Masking
- None (open label)
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme FAYETTE, Doctor, Principal investigator, Centre Léon Bérard, Lyon, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03421912
- Sponsor's protocol ID
- CICAFIX - ET17-011
- Acronym
- CICAFIX
- Status last verified
- Jul 2021
- First submitted
- 29 Jan 2018
- Last updated
- 9 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Monocentric Randomized Study Evaluating the Satisfaction and Quality of Life of Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGRF) in Carcinomas Squamous Cells of the Head and Neck, Colorectal Cancers or Lung Cancers
- ClinicalTrials.gov ID
- NCT03421912
- Acronym / sponsor ID
- CICAFIX / CICAFIX - ET17-011
- Conditions
- Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Non Small Cell Lung Cancer, Epidermal Growth Factor Receptor Inhibitor
- Keywords
- Prevention strategy, Cutaneous toxicity, Quality of life, Patient satisfaction, Dermatology Life Quality Index (DLQI), Epidermal Repair Score (SCOREPI), Topical treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 16 Feb 2018 (actual)
- Primary completion
- 11 Apr 2021 (actual)
- Study completion
- 11 May 2021 (actual)
- First posted
- 5 Feb 2018 (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.
This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary
Detailed description
The arrival of new therapeutic strategies such as targeted therapies has led to real progress in the treatment of cancers. Tyrosine kinase inhibitors and antibodies to epidermal growth factor receptors (EGFR), or iEGFR, target one of the major pathways of tumor cell proliferation. These treatments have demonstrated their interest in the treatment of certain advanced solid malignant tumors (head and neck cancer, colorectal cancer, bronchial cancer).
Although having a much better tolerance profile than the "classical" cytotoxic treatments used in the same indications, these treatments, however, have frequent cutaneous toxicities that are inconvenient for patients. According to the molecules, they can affect 80 to 90% of patients treated from the first weeks of treatment and to different degrees. They appear as well in the skin (acneiform rash, erythema, desquamation, xerosis, pruritus) as skin appendages (paronychia, alopecia).
The consequences of these adverse effects are significant, which may be at the origin of a decrease in dose or even of a stop of anti-tumoral treatment inducing a reduction of the expected clinical benefit. In addition, they represent for the patient a real source of inconvenience and pain, which can impact the quality of life (choice of dress, feeling of shame because of the appearance of the skin ...) and impact the adherence to iEGFR treatment.
Management includes first and foremost preventive measures: the use of moisturizing topicals and dermatological soap-free surgras is recommended as soon as iEGFR treatment is initiated, and preventive systemic treatment with cyclins (doxycycline 100 mg daily) is proposed for at least 6 weeks and then reevaluated for skin toxicity.
In case of appearance of skin toxicities, it is initially prescribed in common practice a topical such as Dexeryl (used in many hospitals as standard) or Cicaplast Balm B5 La Roche Posay (used in current practice at Léon Bérard Center). In a second step, topical corticosteroids are prescribed, depending on the grade of toxicity.
There is, however, no validated argument in the literature to guide the choice of clinicians to use either of these topics. Cicaplast balm B5 (antibacterial, repairing damaged skin, moisturizing and relieving feelings of discomfort) would limit the aggravation of skin toxicities and therefore the use of pharmacological measures, including topical corticosteroids class 3 or 4 may long term, weaken the skin barrier even more.
This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Arm A : Use of Cicaplast balm B5 since de first day of iEGFR initiation treatment for 30 days Arm B : Use of Dexeryl cream since de first day of iEGFR initiation treatment for 30 days
| Arm | Type | Receives |
|---|---|---|
| Arm A : Cicaplast balm B5 | Experimental | Other: Cicaplast Balm B5Use of Cicaplast balm B5, 2 to 3 applications per day, since the first day of iEGFR treatment initiation for 30 days to avoid or limit appearance of cutaneous toxicities related to iEGFR treatment. |
| Arm B : Dexeryl | Active comparator | Other: DexerylUse of Dexeryl, 2 to 3 applications per day, since de first day of iEGFR treatment initiation for 30 days to avoid or limit appearence of cutaneous toxicities related to iEGFR treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥ 18 years.
- Patient with recurrent and / or metastatic head and neck squamous cell carcinoma OR metastatic colorectal cancer with non-mutated RAS gene (wild-type) OR non-small cell lung cancer (NSCLC) with EGFR activating mutations.
- Treated for the first time by an iEGFR having received a marketing authorization.
- Having signed a consent to participate in the study.
- Affiliated to a health insurance plan (or beneficiary of such a plan).
Key exclusion criteria (6 listed)
- Concomitant radiotherapy.
- Unresolved skin toxicity from previous treatment, whatever it may be.
- Concomitant use of other topical treatments.
- Known hypersensitivity to at least one of the components of the topicals used.
- Pregnant or lactating women.
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 |
|---|---|---|
| Cicaplast Balm B5The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers | Other | Arm A : Cicaplast balm B5 |
| DexerylThe patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers | Other | Arm B : Dexeryl |
Primary outcome
Overall patient satisfaction after 30 days treatment
Time frame: After 30 days of treatment or at the end of treatment for patient who interrupt the treatment before 30 days
Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm
8 secondary outcomes
Overall patient satisfaction after 60 days treatment
Time frame: After 60 days of treatment or at the end of treatment for patient who interrupt the treatment before 60 days
Patient Quality of life
Time frame: At inclusion, after 30 and 60 days of treatment
Cutaneous toxicities evaluation using Epidermal Repair Score (SCOREPI)
Time frame: After 15, 30 and 60 days of treatment
Cutaneous toxicities evaluation using Common Terminology Criteria for Adverse Events (CTCAE) version 4
Time frame: After 15, 30 and 60 days of treatment
Modification/Interruption/Discontinuing iEGFR treatment rate
Time frame: Continuously up to 30 days after starting treatment
DLQI and SCOREPI scores correlation
Time frame: After 30 and 60 days of treatment
Topical observance
Time frame: Between the 1st day and the 15th day of treatment, and between the 15th and the 30th day of treatment
Use rate of dermocorticoids
Time frame: Continously up to 60 days after starting treatment
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 9 Jul 2021.
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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.
Jérôme FAYETTE, Doctor principal investigator
Centre Léon Bérard, Lyon, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cicaplast Balm B5 and Dexeryl in people with Head and Neck Squamous Cell Carcinoma and Colorectal Cancer, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. 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 9 Jul 2021. 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 France. 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?
Overall patient satisfaction after 30 days treatment (time frame: After 30 days of treatment or at the end of treatment for patient who interrupt the treatment before 30 days). 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 9 Jul 2021.