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Cicaderma Efficacy vs Standard Care of Sites in Preventing Radiodermatitis in Non-metastatic Breast Cancer Patients (CICA-RT)

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ClinicalTrials.gov Identifier: NCT04300829
Recruitment Status : Not yet recruiting
First Posted : March 9, 2020
Last Update Posted : March 9, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

Brief 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 for Adverse Events-Version (NCI-CTCAE-V5)

Condition or disease Intervention/treatment Phase
Breast Adenocarcinoma Radiation Dermatitis Radiation Toxicity Drug: cicaderma + simple hygiene rules Other: Simple hygiene rules and a maximum of one topical treatment Phase 3

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
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
Estimated Study Start Date : March 9, 2020
Estimated Primary Completion Date : May 9, 2022
Estimated Study Completion Date : October 9, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Simple hygiene rules of the site + Cicaderma ointment
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)
Drug: cicaderma + simple hygiene rules
Cicaderma ointment (2 applications / day: after the radiotherapy session) and in the evening) + simple hygiene rules
Other Name: Cicaderma ointment and simple hygiene rules

Active Comparator: Preventive standard cares
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
Other: Simple hygiene rules and a maximum of one topical treatment
Simple hygiene rules according to the site recommandations including eventually a maximum of one topical treatment




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Patients' satisfaction [ Time Frame: 30+/-4 days after the end of radiotherapy interruption ]
    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)

  2. Patients' quality of life: DLQI questionnaire [ Time Frame: Up to 30+/-4 days after the end of radiotherapy interruption ]
    Patients' quality of life evaluated using the Dermatology Life Quality Index (DLQI) questionnaire (validated questionnaire composed of 10 items leading to a global score)

  3. Patients' pain in the irradiated area: numeric scale [ Time Frame: Up to 30+/-4 days after the end of radiotherapy interruption ]
    Patients' pain evaluated using a numeric scale from 0 (no pain) to 10 (unbearable pain)

  4. 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 ]
    Temporary or permanent radiotherapy interruption related to the onset of grade 3 radiodermatitis observed during patients' treatment period

  5. Rate of prurit onset whatever the grade [ Time Frame: Up to 30+/-4 days after the end of radiotherapy interruption ]
    Prurit onset whatever the grade observed

  6. Doses of radiation therapy received [ Time Frame: Through radiotherapy completion, an average of 5 weeks ]
    Doses of radiation therapy received during each radiotherapy session

  7. 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 ]
    Onset of the first grade >= 2 cutaneous event (radiodermatitis or prurit)

  8. Compliance with the Cicaderma ointment application (experimental arm) [ Time Frame: Up to 30+/-4 days after the end of radiotherapy ]
    Compliance evaluated according to the ointment tubes brought back by the patients (not used or partially used) and patient's diary

  9. 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 ]
    Cup size

  10. Determination of the factors measured prior to treatment initiation which are associated to the onset of grade ≥2 radiodermatitis (phototype) [ Time Frame: At inclusion ]
    Phototype



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04300829


Contacts
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Contact: Séverine METZGER +33 4.78.78.27.86 severine.metzger@lyon.unicancer.fr

Locations
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France
Institut Sainte-Catherine
Avignon, France, 84000
Institut Curie
Paris, France, 75005
Contact: Youlia KIROVA, MD PhD       youlia.kirova@curie.fr   
Institut Curie
Saint-Cloud, France, 92210
Contact: Youlia KIROVA, MD       youlia.kirova@curie.fr   
Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Séverine RACADOT, MD Centre Leon Berard
Principal Investigator: Youlia KIROVA, MD PhD Institut Curie
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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT04300829    
Other Study ID Numbers: ET19-084 - CICA-RT
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: March 9, 2020
Last Verified: March 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Leon Berard:
Non-metastatic breast cancer
Post operative adjuvant radiotherapy
Radiotherapy cutaneous toxicity
Additional relevant MeSH terms:
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Dermatitis
Radiodermatitis
Skin Diseases
Radiation Injuries
Wounds and Injuries