Breast CancerNCT06474988
Characterization of Biophysical and Mechanical Parameters on Skin of Breast Cancer Patients
An observational study of Breast Cancer and Estrogen Receptor Positive Tumor, run by European Institute of Oncology at 1 site in Italy.
Trial summary
Aim of this study is to characterize the chemical/physical and structural parameters of the skin in patients with breast cancer undergoing oncological adjuvant treatment in order to understand how to prevent and manage adverse skin events during hormone therapy, also through the formulation of new functional… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Breast Cancer, Estrogen Receptor Positive Tumor
- What is being tested?
- Skin tests
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 27 May 2024to 31 May 2025
- 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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Estrogen receptor (ER) positive breast cancer patients undergoing adjuvant therapy
Who may be able to join
- age between 40 and 70 years
- subjects who are receiving treatment with tamoxifen, aromatase inhibitor or paclitaxel in adjuvant therapy +/- adjuvant radiotherapy
- subjects who are receiving hormonal therapy must have suspended any chemotherapy for at least 30 days
Who cannot join
- presence of known chronic skin pathologies before adjuvant treatment start (psoriasis, lupus, atopic dermatitis)
- inability to understand and will
- unavailability to carry out all the tests required by the protocol
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan, 20141
Giulio Tosti, MD, +39 0257489318, giulio.tosti@ieo.it
About this study
Official title: Characterization of Biophysical and Mechanical Parameters on the Skin of Subjects With a Diagnosis of Breast Cancer After Surgery and Undergoing Adjuvant Treatment.
Aim of this study is to characterize the chemical/physical and structural parameters of the skin in patients with breast cancer undergoing oncological adjuvant treatment in order to understand how to prevent and manage adverse skin events during hormone therapy, also through the formulation of new functional dermocosmetics.
Read the detailed description
Breast cancer is the most frequent neoplasm in women in industrialized countries. After surgery, an adjuvant systemic treatment is generally proposed (hormone therapy, chemotherapy, molecular targeted therapy).
Side effects of endocrine treatments, including skin toxicities, are frequent and often underestimated, leading to poor treatment adherence that can compromise therapeutic outcomes. Among adjuvant chemotherapy treatments, one of the most used drug is Paclitaxel: at skin level it can induce rash, dry skin and itching.
The combination of radiotherapy with these oncological treatments could aggravate cutaneous side effects.
Aim of this study is to characterize the chemical/physical and structural parameters of the skin in patints with breast cancer undergoing adjuvant treatment, performing specific skin tests with professional instruments and adequate personnel. The evaluation will be carried out in Estrogen Receptor (ER) positive breast cancer patients undergoing adjuvant therapy with Tamoxifen or Aromatase Inhibitor or Paclitaxel +/- adjuvant radiotherapy.
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor
- Being tested
- Skin tests
- Keywords
- Estrogen Receptor Positive Breast Cancer, Adjuvant Treatment, Skin Toxicity
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skin testsOther
Acquisition of Skindex questionnaire 29 and execution of instrumental skin tests
| Study group | Role | What they receive |
|---|---|---|
| Tamoxifen | Patients who are receiving treatment with tamoxifen in adjuvant setting Receives: Other: Skin tests | |
| Aromatase Inhibitors | Patients who are receiving treatment with an aromatase inhibitor in adjuvant setting Receives: Other: Skin tests | |
| Paclitaxel | Patients who are receiving treatment with Paclitaxel in adjuvant setting Receives: Other: Skin tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forearm hydration degree assessmnent
Forearm hydration degree evaluated using instrumental skin tests
Measured: 1 day
Evaluation of Effects of Skin Disease on Quality of Life
Collection of Skindex29 questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2024
- Study start27 May 2024
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giulio Tosti, MD, Principal investigator, European Istitute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06474988
- Sponsor's protocol ID
- L2-094
- Status last verified
- Jun 2024
- First submitted
- 20 Jun 2024
- Last updated
- 26 Jun 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 26 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Biophysical and Mechanical Parameters on the Skin of Subjects With a Diagnosis of Breast Cancer After Surgery and Undergoing Adjuvant Treatment.
- ClinicalTrials.gov ID
- NCT06474988
- Acronym / sponsor ID
- L2-094
- Conditions
- Breast Cancer, Estrogen Receptor Positive Tumor
- Keywords
- Estrogen Receptor Positive Breast Cancer, Adjuvant Treatment, Skin Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 27 May 2024 (actual)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2025 (estimated)
- First posted
- 26 Jun 2024 (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.
Aim of this study is to characterize the chemical/physical and structural parameters of the skin in patients with breast cancer undergoing oncological adjuvant treatment in order to understand how to prevent and manage adverse skin events during hormone therapy, also through the formulation of new functional dermocosmetics.
Detailed description
Breast cancer is the most frequent neoplasm in women in industrialized countries. After surgery, an adjuvant systemic treatment is generally proposed (hormone therapy, chemotherapy, molecular targeted therapy).
Side effects of endocrine treatments, including skin toxicities, are frequent and often underestimated, leading to poor treatment adherence that can compromise therapeutic outcomes. Among adjuvant chemotherapy treatments, one of the most used drug is Paclitaxel: at skin level it can induce rash, dry skin and itching.
The combination of radiotherapy with these oncological treatments could aggravate cutaneous side effects.
Aim of this study is to characterize the chemical/physical and structural parameters of the skin in patints with breast cancer undergoing adjuvant treatment, performing specific skin tests with professional instruments and adequate personnel. The evaluation will be carried out in Estrogen Receptor (ER) positive breast cancer patients undergoing adjuvant therapy with Tamoxifen or Aromatase Inhibitor or Paclitaxel +/- adjuvant radiotherapy.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Tamoxifen | – | Other: Skin testsPatients who are receiving treatment with tamoxifen in adjuvant setting |
| Aromatase Inhibitors | – | Other: Skin testsPatients who are receiving treatment with an aromatase inhibitor in adjuvant setting |
| Paclitaxel | – | Other: Skin testsPatients who are receiving treatment with Paclitaxel in adjuvant setting |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Estrogen receptor (ER) positive breast cancer patients undergoing adjuvant therapy
Key inclusion criteria (3 listed)
- age between 40 and 70 years
- subjects who are receiving treatment with tamoxifen, aromatase inhibitor or paclitaxel in adjuvant therapy +/- adjuvant radiotherapy
- subjects who are receiving hormonal therapy must have suspended any chemotherapy for at least 30 days
Key exclusion criteria (3 listed)
- presence of known chronic skin pathologies before adjuvant treatment start (psoriasis, lupus, atopic dermatitis)
- inability to understand and will
- unavailability to carry out all the tests required by the protocol
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 |
|---|---|---|
| Skin testsAcquisition of Skindex questionnaire 29 and execution of instrumental skin tests | Other | Aromatase Inhibitors, Paclitaxel, Tamoxifen |
Primary outcome
Forearm hydration degree assessmnent
Time frame: 1 day
Forearm hydration degree evaluated using instrumental skin tests
Evaluation of Effects of Skin Disease on Quality of Life
Time frame: 1 day
Collection of Skindex29 questionnaire (minimum value: 1, maximum value: 5 - higher scores mean a greater agreement with the statement)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 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.
Giulio Tosti, MD principal investigator
European Istitute of Oncology
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 Breast Cancer and Estrogen Receptor Positive Tumor, run by European Institute of Oncology at 1 site in Italy.
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 3 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 26 Jun 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 Italy. 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 Giulio Tosti, MD (+39 0257489318, giulio.tosti@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Forearm hydration degree assessmnent (time frame: 1 day). 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 26 Jun 2024.