- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05907551
Study in Patients With Solid Tumor Regarding Access to Dermo-cosmetics and Aesthetic Solutions (DERMOCOS)
Cancer treatments can trigger cutaneous side-effects, as well as nail and hair toxicities. When related to drug treatment, this iatrogeny depends on the type of drug, its dosage and individual susceptibility. Although these dermatological adverse events are rarely serious, they can significantly alter patients' quality of life, and may even necessitate the introduction of curative treatment.
The impact of these side effects can be mitigated by the use of dermo-cosmetic products and aesthetic solutions. However, most of this supportive care is not reimbursed by the health insurance system, representing a source of inequalities in access to healthcare for cancer patients.
Study Overview
Detailed Description
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Manon VOEGELIN
- Phone Number: 33 (0)3 68 33 95 23
- Email: promotion-rc@icans.eu
Study Contact Backup
- Name: Claire VIT
- Phone Number: (0)3 88 25 85 29
- Email: promotion-rc@icans.eu
Study Locations
-
-
-
Strasbourg, France, 67033
- Recruiting
- Institut de cancérologie Strasbourg Europe
-
Contact:
- Nelly ETIENNE-SELLOUM, PharmD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age > 18 years
- Patients with solid tumors (eligible localization include: digestive system, Head and Neck, Breast, Brain, Lung Tumors, Urological and Gynecologic cancers)
- Patients able to read and understand French
- Patients that has expressed their consent and with signed consent form
Exclusion Criteria:
- Minor or patients placed under guardianship or supervision
- Patients unable to read French
- Patients placed under judicial protection
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Patients with Breast Cancer
|
25-items questionnaire
|
|
Patients with Digestive System Cancer
|
25-items questionnaire
|
|
Patients with Head and Neck Cancer
|
25-items questionnaire
|
|
Patients with Nervous System Tumors
|
25-items questionnaire
|
|
Patients with Urological Cancer
|
25-items questionnaire
|
|
Patients with Lung Cancer
|
25-items questionnaire
|
|
Patients with Gynecologic Cancer
|
25-items questionnaire
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe patients' knowledges regarding cutaneous side-effects, nail and hair toxicities induced by anticancer drugs
Time Frame: at inclusion
|
4 items questionnaires
|
at inclusion
|
|
Describe patients' knowledges regarding dermo-cosmetics and aesthetic solutions that can attenuate cutaneous side-effects, nail and hair toxicities induced by anticancer drugs
Time Frame: at inclusion
|
10 items questionnaires
|
at inclusion
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Describe patients' socio-economic profile to assess equity regarding access to dermo-cosmetics and aesthetic solutions
Time Frame: at inclusion
|
11 items questionnaires
|
at inclusion
|
|
Correlate patients' knowledge level depending on tumoral location
Time Frame: at inclusion
|
Tumoral location as described in medical chart
|
at inclusion
|
|
Correlate patients' knowledge level depending on received treatment
Time Frame: at inclusion
|
Type of chemotherapy administered on the day of inclusion as described in medical chart
|
at inclusion
|
|
Correlate patients' knowledge level depending on treatment phase
Time Frame: at inclusion
|
Type of treatment phase (i.e.
neoadjuvant, adjuvant, 1st or 2nd metastatic line) as described in medical chart
|
at inclusion
|
Collaborators and Investigators
Investigators
- Study Chair: Nelly ETIENNE-SELLOUM, PharmD, Institut de cancérologie Strasbourg Europe
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2023-001 (University of Missouri)
- 2023-A00546-39 (Other Identifier: ID-RCB Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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