Breast AdenocarcinomaPhase 3CICA-RTNCT04300829
Cicaderma Efficacy vs Standard Care of Sites in Preventing Radiodermatitis in Non-metastatic Breast Cancer Patients
A Phase 3 study testing cicaderma + simple hygiene rules and Simple hygiene rules and a maximum of one topical treatment in people with Breast Adenocarcinoma and Radiation Dermatitis, run by Centre Leon Berard at 3 sites in France.
Trial summary
Phase III, prospective, interventional, multicentric, comparative, randomized, open study with 2 parallel arms, evaluating the efficacy of Cicaderma ointment vs standard management of each site in preventing the onset of grade > 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Adenocarcinoma, Radiation Dermatitis, Radiation Toxicity
- What is being tested?
- cicaderma + simple hygiene rules and Simple hygiene rules and a maximum of one topical treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 3 sitesFrance
- Study dates
- 6 Jun 2020to 9 Oct 2022
- Phase
- Phase 3
- 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
- Age ≥18 years
- Patient requiring a post-operative radiotherapy (post mastectomy or tumorectomy) for a mammary adenocarcinoma or an unilateral in situ breast cancer histologically documented, early stage of disease (non metastatic)
- Patient with no residual tumor (R0 or R1)
- Patient informed and having given her signed consent
- Patient affiliated to a social security regimen
Who cannot join
- Unsolved cutaneous toxicities of any previous treatment
- Hormonotherapy started prior to radiotherapy
- Concomitant use of other topical treatments than the study treatments on the irradiated area
- Patient treated by concomitant chemotherapy and/or targeted therapy
- Known hypersensibility to at least one component of the topicals used or Cicadema ointment
- Patient for whom follow-up does not seem possible even in the short term
Show all 9Show fewer
- Pregnant or breastfeeding woman
- Participation in another clinical trial that may interfere with the evaluation of the primary endpoint
- Patient Under tutorship or curatorship or deprived of liberty
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Recruiting
Institut Sainte-Catherine
Avignon, 84000
- Recruiting
Institut Curie
Paris, 75005
Youlia KIROVA, MD PhD, youlia.kirova@curie.fr
- Not yet recruiting
Institut Curie
Saint-Cloud, 92210
Youlia KIROVA, MD, youlia.kirova@curie.fr
About this study
Official title: Randomised Multicentric Phase III Study Evaluating the Efficacy of Cicaderma vs Standard Management of Each Site in Preventing Radiodermatitis After Adjuvant Post-operative Breast Irradiation in Patients With Non-metastatic Breast Cancer
Phase III, prospective, interventional, multicentric, comparative, randomized, open study with 2 parallel arms, evaluating the efficacy of Cicaderma ointment vs standard management of each site in preventing the onset of grade > 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)
Read the detailed description
Breast cancer is the most common cancer in women. It accounts for more than 1/3 of new cancer cases and is the 1st cause of death for women.
Management usually includes tumorectomy or mastectomy precede or not by a chemotherapy, then adjuvant irradiation that can be supplemented with adjuvant chemotherapy and / or hormone therapy.
Radiotherapy uses ionizing radiation (photons, electrons ...) to destroy cancer cells and consists in precisely directing these radiations on the area to be treated while preserving as much as possible healthy tissues and surrounding organs.
Radiation-induced dermatitis is a skin lesion that occurs after exposure to ionizing radiation and is commonly seen in patients. Acute radiodermatitis occurs in the days or weeks following the start of irradiation with different degrees of severity (dry or exsudative radiodermatitis, acute radionecrosis) They are responsible for an alteration of patients' quality of life (pain, sensitivity to UV radiation, discomfort sensations ...), which may lead to a temporary or even permanent therapeutic interruption and reduce the probability of tumor control.
The management of these dermatitis is very heterogeneous, no study having demonstrated the superiority of a preventive or curative treatment. Trolamine (Biafine®) is to date the only topic with a Marketing Authorization (MA) for the treatment of radiation-induced secondary erythema.
A study conducted on 254 patients at the Léon Bérard Center from 1999 to 2001 demonstrated that the preventive use of a calendula-based topical was associated with a statistically significant reduction of grade 2 radiodermitis compared to trolamine in patients presenting an early breast cancer treated with post-operative irradiation. However, this calendula ointment, which does not have the MA in the indicated indication, was in practice more difficult to apply than trolamine.
Currently, skin hygiene measures to be applied are systematically explained to patients before carrying out post-operative radiotherapy (cotton clothing, neutral soap, etc.). Some centers such as Center Léon Bérard recommend the systematic use of a topic after each session, while others recommend hygiene measures or implement other options (essential oils ...). However, the effectiveness of these current practices on the prevention of radiodermatitis has not yet been demonstrated.
It is a phase III, prospective, interventional, multicentric, comparative, randomized, open study with 2 parallel arms Patients will be randomized (1 :1) in Arm A (hygiene measures + preventive treatment with Cicaderma ointment) or Arm B (preventive treatment according to the site recommendations (at least the hygiene measures) with a stratification (site, body mass index ≤25 vs >25 and RT hypofractionning).
- Being tested
- cicaderma + simple hygiene rules, Simple hygiene rules and a maximum of one topical treatment
- Keywords
- Non-metastatic breast cancer, Post operative adjuvant radiotherapy, Radiotherapy cutaneous toxicity
- Medical subject headings
- Radiodermatitis, Radiation Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cicaderma + simple hygiene rulesDrug
Also called Cicaderma ointment and simple hygiene rules
Cicaderma ointment (2 applications / day: after the radiotherapy session) and in the evening) + simple hygiene rules
Simple hygiene rules and a maximum of one topical treatmentOther
Simple hygiene rules according to the site recommandations including eventually a maximum of one topical treatment
| Study group | Role | What they receive |
|---|---|---|
| Simple hygiene rules of the site + Cicaderma ointment | Experimental | Hygiene rules (use of a neutral soap, no bath, use of non-alcoholic products, delicate drying of the skin, wearing of cotton clothing) and Cicaderma ointment application) Receives: Drug: cicaderma + simple hygiene rules |
| Preventive standard cares | Active comparator | Preventive standard cares of the site including hygiene rules (use of a neutral soap, no bath, use of non-alcoholic products, delicate drying of the skin, wearing of cotton clothing) and a maximum of one topical treatment Receives: Other: Simple hygiene rules and a maximum of one topical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of the Cicaderma ointment efficacy versus the standard management of each site in preventing the onset of grade >= 2 radiodermatitis (NCI-CTCAE-V5)
Number of patients presenting >= 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)
Measured: Up to 30+/-4 days after the end of radiotherapy interruption
Secondary outcomes (10)
Patients' satisfaction
Patients' satisfaction evaluated using the "Patient's evaluation of the preventive management of radiodermatits" - Likert scale in 5 points (from very unsatisfied to very satisfied)
Measured: 30+/-4 days after the end of radiotherapy interruption
Patients' quality of life: DLQI questionnaire
Patients' quality of life evaluated using the Dermatology Life Quality Index (DLQI) questionnaire (validated questionnaire composed of 10 items leading to a global score)
Measured: Up to 30+/-4 days after the end of radiotherapy interruption
Patients' pain in the irradiated area: numeric scale
Patients' pain evaluated using a numeric scale from 0 (no pain) to 10 (unbearable pain)
Measured: Up to 30+/-4 days after the end of radiotherapy interruption
Rate of temporary or permanent RT interruption related to the onset of grade 3 radiodermatitis
Temporary or permanent radiotherapy interruption related to the onset of grade 3 radiodermatitis observed during patients' treatment period
Measured: Through radiotherapy completion, an average of 5 weeks
Rate of prurit onset whatever the grade
Prurit onset whatever the grade observed
Measured: Up to 30+/-4 days after the end of radiotherapy interruption
Doses of radiation therapy received
Doses of radiation therapy received during each radiotherapy session
Measured: Through radiotherapy completion, an average of 5 weeks
Delay of onset of the first cutaneous event (radiodermatitis or prurit) grade ≥2
Onset of the first grade >= 2 cutaneous event (radiodermatitis or prurit)
Measured: Up to 30+/-4 days after the end of radiotherapy
Compliance with the Cicaderma ointment application (experimental arm)
Compliance evaluated according to the ointment tubes brought back by the patients (not used or partially used) and patient's diary
Measured: Up to 30+/-4 days after the end of radiotherapy
Determination of the factors measured prior to treatment initiation which are associated to the onset of grade ≥2 radiodermatitis (cup size)
Cup size
Measured: At inclusion
Determination of the factors measured prior to treatment initiation which are associated to the onset of grade ≥2 radiodermatitis (phototype)
Phototype
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 posted9 Mar 2020
- Study start6 Jun 2020
- Primary completion9 Sep 2022 (estimated)
- Study completion9 Oct 2022 (estimated)
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 Breast AdenocarcinomaStudies of the same condition, open and under way.
- More trials run by Centre Leon BerardThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, multicentric Phase III study evaluating the Cicaderma ointment efficacy versus standard practice of each site in the prevention of radiodermatitis in patients presenting a non metastatic breast cancer
- Masking
- None (open label)
- Enrolment
- 248 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Séverine RACADOT, MD, Principal investigator, Centre Leon BerardYoulia KIROVA, MD PhD, Principal investigator, Institut Curie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04300829
- Sponsor's protocol ID
- ET19-084 - CICA-RT
- Acronym
- CICA-RT
- Status last verified
- Feb 2021
- First submitted
- 28 Feb 2020
- Last updated
- 4 Feb 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Racadot S, Arnaud A, Schiffler C, Metzger S, Perol D, Kirova Y. Cicaderma(R) in radiation-related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT. Clin Transl Radiat Oncol. 2023 Jun 1;41:100647. doi: 10.1016/j.ctro.2023.100647. eCollection 2023 Jul.
PubMed 37441546
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Multicentric Phase III Study Evaluating the Efficacy of Cicaderma vs Standard Management of Each Site in Preventing Radiodermatitis After Adjuvant Post-operative Breast Irradiation in Patients With Non-metastatic Breast Cancer
- ClinicalTrials.gov ID
- NCT04300829
- Acronym / sponsor ID
- CICA-RT / ET19-084 - CICA-RT
- Keywords
- Non-metastatic breast cancer, Post operative adjuvant radiotherapy, Radiotherapy cutaneous toxicity
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 248 participants (estimated)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 9 Sep 2022 (estimated)
- Study completion
- 9 Oct 2022 (estimated)
- First posted
- 9 Mar 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.
Phase III, prospective, interventional, multicentric, comparative, randomized, open study with 2 parallel arms, evaluating the efficacy of Cicaderma ointment vs standard management of each site in preventing the onset of grade > 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)
Detailed description
Breast cancer is the most common cancer in women. It accounts for more than 1/3 of new cancer cases and is the 1st cause of death for women.
Management usually includes tumorectomy or mastectomy precede or not by a chemotherapy, then adjuvant irradiation that can be supplemented with adjuvant chemotherapy and / or hormone therapy.
Radiotherapy uses ionizing radiation (photons, electrons ...) to destroy cancer cells and consists in precisely directing these radiations on the area to be treated while preserving as much as possible healthy tissues and surrounding organs.
Radiation-induced dermatitis is a skin lesion that occurs after exposure to ionizing radiation and is commonly seen in patients. Acute radiodermatitis occurs in the days or weeks following the start of irradiation with different degrees of severity (dry or exsudative radiodermatitis, acute radionecrosis) They are responsible for an alteration of patients' quality of life (pain, sensitivity to UV radiation, discomfort sensations ...), which may lead to a temporary or even permanent therapeutic interruption and reduce the probability of tumor control.
The management of these dermatitis is very heterogeneous, no study having demonstrated the superiority of a preventive or curative treatment. Trolamine (Biafine®) is to date the only topic with a Marketing Authorization (MA) for the treatment of radiation-induced secondary erythema.
A study conducted on 254 patients at the Léon Bérard Center from 1999 to 2001 demonstrated that the preventive use of a calendula-based topical was associated with a statistically significant reduction of grade 2 radiodermitis compared to trolamine in patients presenting an early breast cancer treated with post-operative irradiation. However, this calendula ointment, which does not have the MA in the indicated indication, was in practice more difficult to apply than trolamine.
Currently, skin hygiene measures to be applied are systematically explained to patients before carrying out post-operative radiotherapy (cotton clothing, neutral soap, etc.). Some centers such as Center Léon Bérard recommend the systematic use of a topic after each session, while others recommend hygiene measures or implement other options (essential oils ...). However, the effectiveness of these current practices on the prevention of radiodermatitis has not yet been demonstrated.
It is a phase III, prospective, interventional, multicentric, comparative, randomized, open study with 2 parallel arms Patients will be randomized (1 :1) in Arm A (hygiene measures + preventive treatment with Cicaderma ointment) or Arm B (preventive treatment according to the site recommendations (at least the hygiene measures) with a stratification (site, body mass index ≤25 vs >25 and RT hypofractionning).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, multicentric Phase III study evaluating the Cicaderma ointment efficacy versus standard practice of each site in the prevention of radiodermatitis in patients presenting a non metastatic breast cancer
| Arm | Type | Receives |
|---|---|---|
| Simple hygiene rules of the site + Cicaderma ointment | Experimental | Drug: cicaderma + simple hygiene rulesHygiene rules (use of a neutral soap, no bath, use of non-alcoholic products, delicate drying of the skin, wearing of cotton clothing) and Cicaderma ointment application) |
| Preventive standard cares | Active comparator | Other: Simple hygiene rules and a maximum of one topical treatmentPreventive standard cares of the site including hygiene rules (use of a neutral soap, no bath, use of non-alcoholic products, delicate drying of the skin, wearing of cotton clothing) and a maximum of one topical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years
- Patient requiring a post-operative radiotherapy (post mastectomy or tumorectomy) for a mammary adenocarcinoma or an unilateral in situ breast cancer histologically documented, early stage of disease (non metastatic)
- Patient with no residual tumor (R0 or R1)
- Patient informed and having given her signed consent
- Patient affiliated to a social security regimen
Key exclusion criteria (9 listed)
- Unsolved cutaneous toxicities of any previous treatment
- Hormonotherapy started prior to radiotherapy
- Concomitant use of other topical treatments than the study treatments on the irradiated area
- Patient treated by concomitant chemotherapy and/or targeted therapy
- Known hypersensibility to at least one component of the topicals used or Cicadema ointment
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 |
|---|---|---|
| cicaderma + simple hygiene rulesAlso: Cicaderma ointment and simple hygiene rulesCicaderma ointment (2 applications / day: after the radiotherapy session) and in the evening) + simple hygiene rules | Drug | Simple hygiene rules of the site + Cicaderma ointment |
| Simple hygiene rules and a maximum of one topical treatmentSimple hygiene rules according to the site recommandations including eventually a maximum of one topical treatment | Other | Preventive standard cares |
Primary outcome
Comparison of the Cicaderma ointment efficacy versus the standard management of each site in preventing the onset of grade >= 2 radiodermatitis (NCI-CTCAE-V5)
Time frame: Up to 30+/-4 days after the end of radiotherapy interruption
Number of patients presenting >= 2 radiodermatitis according to the National Cancer Institute - Common Terminology Criteria for Adverse Events-Version (NCI-CTCAE-V5)
10 secondary outcomes
Patients' satisfaction
Time frame: 30+/-4 days after the end of radiotherapy interruption
Patients' quality of life: DLQI questionnaire
Time frame: Up to 30+/-4 days after the end of radiotherapy interruption
Patients' pain in the irradiated area: numeric scale
Time frame: Up to 30+/-4 days after the end of radiotherapy interruption
Rate of temporary or permanent RT interruption related to the onset of grade 3 radiodermatitis
Time frame: Through radiotherapy completion, an average of 5 weeks
Rate of prurit onset whatever the grade
Time frame: Up to 30+/-4 days after the end of radiotherapy interruption
Doses of radiation therapy received
Time frame: Through radiotherapy completion, an average of 5 weeks
Delay of onset of the first cutaneous event (radiodermatitis or prurit) grade ≥2
Time frame: Up to 30+/-4 days after the end of radiotherapy
Compliance with the Cicaderma ointment application (experimental arm)
Time frame: Up to 30+/-4 days after the end of radiotherapy
Determination of the factors measured prior to treatment initiation which are associated to the onset of grade ≥2 radiodermatitis (cup size)
Time frame: At inclusion
Determination of the factors measured prior to treatment initiation which are associated to the onset of grade ≥2 radiodermatitis (phototype)
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 4 Feb 2021.
- Derived from this study: PubMed 37441546Racadot S, Arnaud A, Schiffler C, Metzger S, Perol D, Kirova Y. Cicaderma(R) in radiation-related dermatitis of breast cancer: Results from the multicentric randomised phase III CICA-RT. Clin Transl Radiat Oncol. 2023 Jun 1;41:100647. doi: 10.1016/j.ctro.2023.100647. eCollection 2023 Jul.
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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.
Séverine RACADOT, MD principal investigator
Centre Leon Berard
Youlia KIROVA, MD PhD principal investigator
Institut Curie
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing cicaderma + simple hygiene rules and Simple hygiene rules and a maximum of one topical treatment in people with Breast Adenocarcinoma and Radiation Dermatitis, run by Centre Leon Berard at 3 sites 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 9 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 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Séverine METZGER (+33 4.78.78.27.86, severine.metzger@lyon.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the Cicaderma ointment efficacy versus the standard management of each site in preventing the onset of grade >= 2 radiodermatitis (NCI-CTCAE-V5) (time frame: Up to 30+/-4 days after the end of radiotherapy interruption). 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 NCT04300829, 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 4 Feb 2021.