NeoplasmsDERMOCOSNCT05907551
Study in Patients With Solid Tumor Regarding Access to Dermo-cosmetics and Aesthetic Solutions
An observational study of Neoplasms, run by Institut de cancérologie Strasbourg Europe at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasms
- What is being tested?
- Questionnaires
- How many people
- 210 participants
- Where
- 1 siteFrance
- Study dates
- 25 Jul 2023to 25 Oct 2023
- Phase
- Observational
- 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
- Adult, Older adult
Study population: This study will enroll patients with solid tumors in 7 different cohorts according to tumor location (30 patients per location)
Who may be able to join
- 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
Who cannot join
- Minor or patients placed under guardianship or supervision
- Patients unable to read French
- Patients placed under judicial protection
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Institut de cancérologie Strasbourg Europe
Strasbourg, 67033
Nelly ETIENNE-SELLOUM, PharmD
About this study
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.
Read the detailed description
This study aims at establishing, in a cohort of patients with solid tumors, the state of their knowledges, given information and their financial capacities regarding access to dermo-cosmetics and aesthetic solutions, that are used in the attenuation of cancer treatments' side-effects.
- Conditions
- Neoplasms
- Being tested
- Questionnaires
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnairesOther
25-items questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Patients with Digestive System Cancer | Not described Receives: Other: Questionnaires | |
| Patients with Head and Neck Cancer | Not described Receives: Other: Questionnaires | |
| Patients with Breast Cancer | Not described Receives: Other: Questionnaires | |
| Patients with Nervous System Tumors | Not described Receives: Other: Questionnaires | |
| Patients with Urological Cancer | Not described Receives: Other: Questionnaires | |
| Patients with Lung Cancer | Not described Receives: Other: Questionnaires | |
| Patients with Gynecologic Cancer | Not described Receives: Other: Questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Describe patients' knowledges regarding cutaneous side-effects, nail and hair toxicities induced by anticancer drugs
4 items questionnaires
Measured: 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
10 items questionnaires
Measured: at inclusion
Secondary outcomes (4)
Describe patients' socio-economic profile to assess equity regarding access to dermo-cosmetics and aesthetic solutions
11 items questionnaires
Measured: at inclusion
Correlate patients' knowledge level depending on tumoral location
Tumoral location as described in medical chart
Measured: at inclusion
Correlate patients' knowledge level depending on received treatment
Type of chemotherapy administered on the day of inclusion as described in medical chart
Measured: at inclusion
Correlate patients' knowledge level depending on treatment phase
Type of treatment phase (i.e. neoadjuvant, adjuvant, 1st or 2nd metastatic line) as described in medical chart
Measured: at inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start25 Jul 2023
- Primary completion25 Oct 2023 (estimated)
- Study completion25 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut de cancérologie Strasbourg Europe
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nelly ETIENNE-SELLOUM, PharmD, Study chair, Institut de cancérologie Strasbourg Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05907551
- Sponsor's protocol ID
- 2023-001
- Other IDs
- 2023-A00546-39
- Acronym
- DERMOCOS
- Status last verified
- Aug 2023
- First submitted
- 8 Jun 2023
- Last updated
- 22 Aug 2023
- 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 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study in Patients With Solid Tumor Regarding Access to Dermo-cosmetics and Aesthetic Solutions
- ClinicalTrials.gov ID
- NCT05907551
- Acronym / sponsor ID
- DERMOCOS / 2023-001
- Conditions
- Neoplasms
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Institut de cancérologie Strasbourg EuropeUniversity, hospital or other
- Study start
- 25 Jul 2023 (actual)
- Primary completion
- 25 Oct 2023 (estimated)
- Study completion
- 25 Oct 2023 (estimated)
- First posted
- 18 Jun 2023 (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.
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.
Detailed description
This study aims at establishing, in a cohort of patients with solid tumors, the state of their knowledges, given information and their financial capacities regarding access to dermo-cosmetics and aesthetic solutions, that are used in the attenuation of cancer treatments' side-effects.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| Patients with Digestive System Cancer | – | Other: Questionnaires |
| Patients with Head and Neck Cancer | – | Other: Questionnaires |
| Patients with Breast Cancer | – | Other: Questionnaires |
| Patients with Nervous System Tumors | – | Other: Questionnaires |
| Patients with Urological Cancer | – | Other: Questionnaires |
| Patients with Lung Cancer | – | Other: Questionnaires |
| Patients with Gynecologic Cancer | – | Other: Questionnaires |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- This study will enroll patients with solid tumors in 7 different cohorts according to tumor location (30 patients per location)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Minor or patients placed under guardianship or supervision
- Patients unable to read French
- Patients placed under judicial protection
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 |
|---|---|---|
| Questionnaires25-items questionnaire | Other | Patients with Breast Cancer, Patients with Digestive System Cancer, Patients with Gynecologic Cancer, Patients with Head and Neck Cancer, Patients with Lung Cancer, Patients with Nervous System Tumors, Patients with Urological Cancer |
Primary outcome
Describe patients' knowledges regarding cutaneous side-effects, nail and hair toxicities induced by anticancer drugs
Time frame: at inclusion
4 items questionnaires
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
4 secondary outcomes
Describe patients' socio-economic profile to assess equity regarding access to dermo-cosmetics and aesthetic solutions
Time frame: at inclusion
Correlate patients' knowledge level depending on tumoral location
Time frame: at inclusion
Correlate patients' knowledge level depending on received treatment
Time frame: at inclusion
Correlate patients' knowledge level depending on treatment phase
Time frame: at inclusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
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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.
Nelly ETIENNE-SELLOUM, PharmD study chair
Institut de cancérologie Strasbourg Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neoplasms, run by Institut de cancérologie Strasbourg Europe 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 22 Aug 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Manon VOEGELIN ((0)3 68 33 95 23 ext. 33, promotion-rc@icans.eu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe patients' knowledges regarding cutaneous side-effects, nail and hair toxicities induced by anticancer drugs (time frame: at inclusion). The study lists 2 primary outcomes in all. 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 22 Aug 2023.