Local Breast Cancer PatientsCOSMIKNCT03684135
Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure
A study testing Cosmetics in people with Local Breast Cancer Patients, run by Centre Jean Perrin at 1 site in France.
Trial summary
The purpose of this study is to assess the satisfaction, the observance, the intolerance, the qualitative appreciation and the expectations of the patients related to the use of the cosmetic products ("Tendre Caresse au cold cream" body cream and "Crème de douche" face and body cleanser from Cosmétosource) during… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Local Breast Cancer Patients
- What is being tested?
- Cosmetics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 3 Aug 2018to 30 Nov 2020
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Woman,
- Age > or = 18 years,
- Performance status > or = 1 (according to WHO criteria),
- Patient with histologically proven breast cancer, not metastasized,
- Patient treated with neoadjuvant or adjuvant chemotherapy,
- Absence of cutaneous lesions related to the pathology,
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- Patient fluent in the French language,
- Patient affiliated to a social security scheme,
- Obtaining written, signed and dated informed consent.
Who cannot join
- Metastatic breast cancer,
- Local relapse of breast cancer
- History of cancer in the 5 years preceding the entry into the trial,
- Patient already treated with chemotherapy,
- Medical contraindications to the use of cosmetic products and the prescription of a spa treatment,
- Patient deprived of liberty or under guardianship.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the satisfaction, the observance, the intolerance, the qualitative appreciation and the expectations of the patients related to the use of the cosmetic products ("Tendre Caresse au cold cream" body cream and "Crème de douche" face and body cleanser from Cosmétosource) during chemotherapy and post-treatment thermal cure
- Conditions
- Local Breast Cancer Patients
- Being tested
- Cosmetics
- Keywords
- Breast cancer, Cosmetics, Satisfaction, Chemotherapy, Thermal cure
- Medical subject headings
- Breast Neoplasms, Personal Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CosmeticsOther
"Tendre Caresse au cold cream" body cream from Cosmétosource "Crème de douche" face and body cleanser from Cosmétosource
| Study group | Role | What they receive |
|---|---|---|
| Use of cosmetics during chemotherapy and thermal cure | Experimental | Use of cosmetics during chemotherapy and post-treatment thermal cure Receives: Other: Cosmetics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean satisfaction related to the use of cosmetics during chemotherapy using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
Measured: 6 months
Mean compliance related to the use of cosmetics during chemotherapy by asking if yes or no the products was stopped.
The compliance will be measured by questions asking if patients stopped the use of cosmetics.
Measured: 6 months
Percentage of patients declaring skin problems after the use of these 2 cosmetics
Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.
Measured: 6 months
Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good
The qualitative assessment of cosmetics will be measured by questions asking about the texture, the odour, the oiliness, the application and the absorption of the 2 cosmetic products
Measured: 6 months
Patient expectations related to the use of cosmetics during chemotherapy
Patient expectations will be measured by questions asking about the reason why the stopped the use of these 2 cosmetics and by all answers given for the odour, the texture, the oiliness, the application and the absorption
Measured: 6 months
Secondary outcomes (5)
Mean satisfaction related to the use of cosmetics during post-treatment thermal cure using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
Measured: 1 year
Mean compliance related to the use of cosmetics during post-treatment thermal cure by asking if yes or no the products was stopped
The compliance will be measured by questions asking if patients stopped the use of cosmetics
Measured: 1 year
Percentage of patients declaring skin problems after the use of these 2 cosmetics
Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.
Measured: 1 year
Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good
The qualitative assessment of cosmetics will be measured by questions asking about the texture, the odour, the oiliness, the application and the absorption of the 2 cosmetic products
Measured: 1 year
Patient expectations related to the use of cosmetics during post-treatment thermal cure
Patient expectations will be measured by questions asking about the reason why the stopped the use of these 2 cosmetics and by all answers given for the odour, the texture, the oiliness, the application and the absorption
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2018
- Study start3 Aug 2018
- Primary completion26 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Local Breast Cancer PatientsStudies 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Jean Perrin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xavier DURANDO, Principal investigator, Centre Jean Perrin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03684135
- Sponsor's protocol ID
- 2017-004938-28
- Other IDs
- 2017
- Acronym
- COSMIK
- Status last verified
- Jan 2021
- First submitted
- 11 Jul 2018
- Last updated
- 13 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Passildas J, Abrial C, Molnar I, Mouret-Reynier MA, Chalaphy J, Klein M, Durando X. Patient-reported satisfaction with thermal water-based cosmetic products in breast cancer patients undergoing chemotherapy: a feasibility study. Cancer Treat Res Commun. 2026;47:101168. doi: 10.1016/j.ctarc.2026.101168. Epub 2026 Mar 4.
PubMed 41812302
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Satisfaction Assessment of Patients With Local Breast Cancer When Using Cosmetics During Chemotherapy and Post-treatment Thermal Cure
- ClinicalTrials.gov ID
- NCT03684135
- Acronym / sponsor ID
- COSMIK / 2017-004938-28
- Conditions
- Local Breast Cancer Patients
- Keywords
- Breast cancer, Cosmetics, Satisfaction, Chemotherapy, Thermal cure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Centre Jean PerrinUniversity, hospital or other
- Study start
- 3 Aug 2018 (actual)
- Primary completion
- 26 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 25 Sep 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.
The purpose of this study is to assess the satisfaction, the observance, the intolerance, the qualitative appreciation and the expectations of the patients related to the use of the cosmetic products ("Tendre Caresse au cold cream" body cream and "Crème de douche" face and body cleanser from Cosmétosource) during chemotherapy and post-treatment thermal cure
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of cosmetics during chemotherapy and thermal cure | Experimental | Other: CosmeticsUse of cosmetics during chemotherapy and post-treatment thermal cure |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Woman,
- Age > or = 18 years,
- Performance status > or = 1 (according to WHO criteria),
- Patient with histologically proven breast cancer, not metastasized,
- Patient treated with neoadjuvant or adjuvant chemotherapy,
Key exclusion criteria (6 listed)
- Metastatic breast cancer,
- Local relapse of breast cancer
- History of cancer in the 5 years preceding the entry into the trial,
- Patient already treated with chemotherapy,
- Medical contraindications to the use of cosmetic products and the prescription of a spa treatment,
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 |
|---|---|---|
| Cosmetics"Tendre Caresse au cold cream" body cream from Cosmétosource "Crème de douche" face and body cleanser from Cosmétosource | Other | Use of cosmetics during chemotherapy and thermal cure |
Primary outcome
Mean satisfaction related to the use of cosmetics during chemotherapy using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
Time frame: 6 months
The mean satisfaction will be assessed using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
Mean compliance related to the use of cosmetics during chemotherapy by asking if yes or no the products was stopped.
Time frame: 6 months
The compliance will be measured by questions asking if patients stopped the use of cosmetics.
Percentage of patients declaring skin problems after the use of these 2 cosmetics
Time frame: 6 months
Skin problems will be measured by questions asking if yes or no the skin was moisturized, oily, tugging or nice at touching.
Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good
Time frame: 6 months
The qualitative assessment of cosmetics will be measured by questions asking about the texture, the odour, the oiliness, the application and the absorption of the 2 cosmetic products
Patient expectations related to the use of cosmetics during chemotherapy
Time frame: 6 months
Patient expectations will be measured by questions asking about the reason why the stopped the use of these 2 cosmetics and by all answers given for the odour, the texture, the oiliness, the application and the absorption
5 secondary outcomes
Mean satisfaction related to the use of cosmetics during post-treatment thermal cure using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied).
Time frame: 1 year
Mean compliance related to the use of cosmetics during post-treatment thermal cure by asking if yes or no the products was stopped
Time frame: 1 year
Percentage of patients declaring skin problems after the use of these 2 cosmetics
Time frame: 1 year
Qualitative assessment of cosmetics : percentage of patients feeling that the products texture/oiliness/application/absorption is good/not good
Time frame: 1 year
Patient expectations related to the use of cosmetics during post-treatment thermal cure
Time frame: 1 year
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 13 Jan 2021.
- Derived from this study: PubMed 41812302Passildas J, Abrial C, Molnar I, Mouret-Reynier MA, Chalaphy J, Klein M, Durando X. Patient-reported satisfaction with thermal water-based cosmetic products in breast cancer patients undergoing chemotherapy: a feasibility study. Cancer Treat Res Commun. 2026;47:101168. doi: 10.1016/j.ctarc.2026.101168. Epub 2026 Mar 4.
- Individual participant dataSharing planned: No
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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.
Xavier DURANDO principal investigator
Centre Jean Perrin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cosmetics in people with Local Breast Cancer Patients, run by Centre Jean Perrin 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 9 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 13 Jan 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?
Mean satisfaction related to the use of cosmetics during chemotherapy using a visual analog score (VAS) ranging from 0 (not satisfied) to 10 (satisfied). (time frame: 6 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03684135, which also lists 1 linked publication.
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 13 Jan 2021.