Solid Tumor, AdultDERMACLICNCT04402606
Study on Skin Toxicities Induced by Cancer Treatments
A study testing Evaluation on skin toxicities in people with Solid Tumor, Adult and Breast Cancer, run by Institut Curie at 1 site in France.
Trial summary
The skin toxicities will be evaluated on patient (male or female) with an indication of cancer treatment in the case of solid tumor of the breast, or lung. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor, Adult, Breast Cancer, Lung Cancer
- What is being tested?
- Evaluation on skin toxicities
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 292 participants
- Where
- 1 siteFrance
- Study dates
- 25 Nov 2020to 15 Apr 2024
- 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
- Patient, male or female, aged 18 years and older, with a solid tumor breast or lung, localized, locally advanced or not, metastatic or not;
- Patient in medical oncology consultation requiring systemic anti-tumor therapy (chemotherapy, targeted therapy, hormone therapy, immunotherapy) in neo-adjuvant, adjuvant or metastatic;
- Treatment planned for a minimum period of 3 months (from the date of inclusion);
- Having a social security protection;
- Signed informed consent form of the study.
Who cannot join
- Patient treated for lymphoma, leukemia or inflammatory breast cancer ;
- Patient with a solid tumour which location is other than breast or lung;
- Patient with a tumor wound ;
- Patient with a general condition > 2 at baseline (ECOG classification) ;
- Patient receiving anti-tumor treatment with radiotherapy exclusively or associated with concomitant radiotherapy ;
- Patient unable to receive information about the study and to give consent ;
- Persons deprived of liberty or guardianship ;
- Impossible submission to study procedures for geographical or psychological reasons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: DERMACLIC : Study on Skin Toxicities Induced by Cancer Treatments
The skin toxicities will be evaluated on patient (male or female) with an indication of cancer treatment in the case of solid tumor of the breast, or lung.
- Conditions
- Solid Tumor, Adult, Breast Cancer, Lung Cancer
- Being tested
- Evaluation on skin toxicities
- Medical subject headings
- Breast Neoplasms, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation on skin toxicitiesOther
Measurements will be carried out using specific tools, such as the cutaneous ultrasound system (measurement of the skin layers thicknesses, the cutometer (measurement of the elasticity of the skin), the corneometer (measurement of the hydration of the skin), the pH meter (measuring the pH of the skin), the colorimeter (measuring the color of the skin), the tewameter (measuring the insensible loss of water), the sebometer (measuring sebum).
| Study group | Role | What they receive |
|---|---|---|
| Evaluation on skin toxicities | Experimental | This evaluation consists on a clinical examination of the skin and the realization of the cutaneous measurements of reference on 4 sites frequently exposed to the cutaneous toxicities: face, neckline, palms of the hands and soles of the feet. Receives: Other: Evaluation on skin toxicities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimate the rates of severe skin toxicities (grade 2) induced by cancer treatments, at 8 months after the start of treatment.
Severity of cutaneous toxicities at 8 months after the start of treatment (grade > 2 according to the NCI-CTCAE classification version 4.03), induced by the anticancer treatments.
Measured: 8 months
Secondary outcomes (21)
Evaluate the thickness, firmness, tone, viscosity of the skin in case of skin toxicities
The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. A cutaneous ultrasound system will be used to evaluate thickness of the skin and a cutometer will be used to evaluate firmness, tone and viscosity of the skin. The measurement in millimeters will be used to assess this outcome measure.
Measured: 8 months
Evaluate skin color in case of skin toxicities
The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. A colorimeter will be used to evaluate skin color. No unit will be used to assess this outcome measure.
Measured: 8 months
Evaluate the skin pH in case of skin toxicities
The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. A pHmeter will be used to evaluate skin pH. No unit will be used to assess this outcome measure
Measured: 8 months
Evaluate the temperature in case of skin toxicities
The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Thermometer will be used to evaluate temperature of the skin. The measurement in degrees Celsius will be used to assess this outcome measure.
Measured: 8 months
Evaluate the quantity of sebum in case of toxicities
The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Sebumeter will be used to evaluate quantity of sebum of the skin. The measurement in microgram/centimeter^2 will be used to assess this outcome measure
Measured: 8 months
Evaluate plantar supports in case of toxicities
The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Podobarometric platform will be used to evaluate plantar supports. The measurement in N/Centimeter^2 will be used to assess this outcome measure.
Measured: 8 months
Evaluate Skin hydration rate in case of skin toxicities
The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Corneometer will be used to evaluate skin hydration rate. No unit will be used to assess this outcome measure.
Measured: 8 months
Evaluate skin elasticity index in case of toxicities
The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Cutometer will be used to evaluate skin elasticy. No unit will be used to assess this outcome measure.
Measured: 8 months
Evaluate insensitive loss of water in case of toxicities
The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Tewameter will be used to evaluate insensitive loss of water. The measurement in gram/meter^2/hour will be used to assess this outcome measure.
Measured: 8 months
Evaluate variation rate of thickness, firmness, tone, viscosity of the skin over the course of the study
A cutaneous ultrasound system will be used to evaluate thickness of the skin and a cutometer will be used to evaluate firmness, tone and viscosity of the skin. The measurement in millimeters will be used to assess this outcome measure. Variations of thickness, firmness, tone, viscosity of the skin will be calculated according to results obtained at M1, M2,M3, M4 and M8. Results will be compared to initial measures at day 0. Variation rate will be estimated in percentage.
Measured: 8 months
Evaluate variation rate of skin color over the course of the study
A colorimeter will be used to evaluate skin color. No unit will be used to assess this outcome measure. Variations of skin color will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.
Measured: 8 months
Evaluate variation rate of skin pH over the course of the study
A pHmeter will be used to evaluate skin pH. No unit will be used to assess this outcome measure. Variations of pH of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage
Measured: 8 months
Evaluate variation rate of skin temperature over the course of the study
A thermometer will be used to evaluate skin temperature. The measurement in degrees Celsius will be used to assess this outcome measure. Variations of temperature of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.
Measured: 8 months
Evaluate variation rate of skin sebum quantity over the course of the study
A sebumeter will be used to evaluate quantity of sebum of the skin. The measurement in microgram/centimeter^2 will be used to assess this outcome measure. Variations of quantity of sebum of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.
Measured: 8 months
Evaluate variation rate of plantar supports over the course of the study
A podobarometric platform will be used to evaluate plantar supports. The measurement in N/Centimeter^2 will be used to assess this outcome measure. Variations of plantar supports will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.
Measured: 8 months
Evaluate variation rate of skin hydration over the course of the study
A corneometer will be used to evaluate skin hydration rate. No unit will be used to assess this outcome measure. Variations of skin hydration of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.
Measured: 8 months
Evaluate variation rate of skin elasticity over the course of the study
A cutometer will be used to evaluate skin elasticy. No unit will be used to assess this outcome measure. Variations of elasticity of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.
Measured: 8 months
Evaluate variation rate of insensitive loss of water of the skin over the course of the study
A tewameter will be used to evaluate insensitive loss of water. The measurement in gram/meter^2/hour will be used to assess this outcome measure. Variations of insensitive loss of water of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.
Measured: 8 months
Evaluate the consequences of cutaneous toxicities on the patient's therapeutic scheme (hold, dosage reduction, change of molecule);
Number of treatment interruptions or dose changes related to skin toxicities;
Measured: 8 months
To evaluate the quality of life of patients at 8 months;
A questionnaire (Medical Outcome Study Short Form - 36 (MOS SF-36) will be completed by patients. This is a scale allowing to assess health regardless of causal pathology, gender, age and treatment, which is related to patients level of well-being. A score from 0 (poor quality of life) to 100 (very good quality of life) will be given;
Measured: 8 months
Define patient profiles likely to develop severe cutaneous toxicity during their anticancer treatment;
During these assessments, a census of skin toxicities (grade >2) will be carried out according to the NCI-CTCAE version 4.03 classification, and the patient's medical record will be analyzed to determine the predictors of skin toxicities.
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2020
- Study start25 Nov 2020
- Primary completion25 Nov 2020
- Study completion15 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 292 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Curie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04402606
- Sponsor's protocol ID
- 2019-A0872-55
- Acronym
- DERMACLIC
- Status last verified
- Apr 2024
- First submitted
- 29 Apr 2020
- Last updated
- 18 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DERMACLIC : Study on Skin Toxicities Induced by Cancer Treatments
- ClinicalTrials.gov ID
- NCT04402606
- Acronym / sponsor ID
- DERMACLIC / 2019-A0872-55
- Conditions
- Solid Tumor, Adult, Breast Cancer, Lung Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 292 participants (actual)
- Lead sponsor
- Institut CurieUniversity, hospital or other
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 15 Apr 2024 (actual)
- First posted
- 27 May 2020 (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 skin toxicities will be evaluated on patient (male or female) with an indication of cancer treatment in the case of solid tumor of the breast, or lung.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Evaluation on skin toxicities | Experimental | Other: Evaluation on skin toxicitiesThis evaluation consists on a clinical examination of the skin and the realization of the cutaneous measurements of reference on 4 sites frequently exposed to the cutaneous toxicities: face, neckline, palms of the hands and soles of the feet. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient, male or female, aged 18 years and older, with a solid tumor breast or lung, localized, locally advanced or not, metastatic or not;
- Patient in medical oncology consultation requiring systemic anti-tumor therapy (chemotherapy, targeted therapy, hormone therapy, immunotherapy) in neo-adjuvant, adjuvant or metastatic;
- Treatment planned for a minimum period of 3 months (from the date of inclusion);
- Having a social security protection;
- Signed informed consent form of the study.
Key exclusion criteria (8 listed)
- Patient treated for lymphoma, leukemia or inflammatory breast cancer ;
- Patient with a solid tumour which location is other than breast or lung;
- Patient with a tumor wound ;
- Patient with a general condition > 2 at baseline (ECOG classification) ;
- Patient receiving anti-tumor treatment with radiotherapy exclusively or associated with concomitant radiotherapy ;
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 |
|---|---|---|
| Evaluation on skin toxicitiesMeasurements will be carried out using specific tools, such as the cutaneous ultrasound system (measurement of the skin layers thicknesses, the cutometer (measurement of the elasticity of the skin), the corneometer (measurement of the hydration of the skin), the pH meter (measuring the pH of the skin), the colorimeter (measuring the color of the skin), the tewameter (measuring the insensible loss of water), the sebometer (measuring sebum). | Other | Evaluation on skin toxicities |
Primary outcome
Estimate the rates of severe skin toxicities (grade 2) induced by cancer treatments, at 8 months after the start of treatment.
Time frame: 8 months
Severity of cutaneous toxicities at 8 months after the start of treatment (grade > 2 according to the NCI-CTCAE classification version 4.03), induced by the anticancer treatments.
21 secondary outcomes
Evaluate the thickness, firmness, tone, viscosity of the skin in case of skin toxicities
Time frame: 8 months
Evaluate skin color in case of skin toxicities
Time frame: 8 months
Evaluate the skin pH in case of skin toxicities
Time frame: 8 months
Evaluate the temperature in case of skin toxicities
Time frame: 8 months
Evaluate the quantity of sebum in case of toxicities
Time frame: 8 months
Evaluate plantar supports in case of toxicities
Time frame: 8 months
Evaluate Skin hydration rate in case of skin toxicities
Time frame: 8 months
Evaluate skin elasticity index in case of toxicities
Time frame: 8 months
Evaluate insensitive loss of water in case of toxicities
Time frame: 8 months
Evaluate variation rate of thickness, firmness, tone, viscosity of the skin over the course of the study
Time frame: 8 months
Evaluate variation rate of skin color over the course of the study
Time frame: 8 months
Evaluate variation rate of skin pH over the course of the study
Time frame: 8 months
Evaluate variation rate of skin temperature over the course of the study
Time frame: 8 months
Evaluate variation rate of skin sebum quantity over the course of the study
Time frame: 8 months
Evaluate variation rate of plantar supports over the course of the study
Time frame: 8 months
Evaluate variation rate of skin hydration over the course of the study
Time frame: 8 months
Evaluate variation rate of skin elasticity over the course of the study
Time frame: 8 months
Evaluate variation rate of insensitive loss of water of the skin over the course of the study
Time frame: 8 months
Evaluate the consequences of cutaneous toxicities on the patient's therapeutic scheme (hold, dosage reduction, change of molecule);
Time frame: 8 months
To evaluate the quality of life of patients at 8 months;
Time frame: 8 months
Define patient profiles likely to develop severe cutaneous toxicity during their anticancer treatment;
Time frame: 8 months
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 18 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation on skin toxicities in people with Solid Tumor, Adult and Breast Cancer, run by Institut Curie 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 8 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 18 Apr 2024. 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?
Estimate the rates of severe skin toxicities (grade 2) induced by cancer treatments, at 8 months after the start of treatment. (time frame: 8 months). 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 18 Apr 2024.