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NCT07917117
Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors
Conditions: Quality of Life, Breast Neoplasms, Skin Aging, Hyaluronic Acid
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 50
Sponsor: Fundacion para la Formacion e Investigacion Sanitarias de la Region de Murcia
Location: Ctra.Madrid-Cartagena, s/n, El Palmar Murcia Murcia
Summary
Systemic treatments such as chemotherapy or monoclonal antibodies are an essential part of oncological treatment in breast cancer, which have demonstrated a survival benefit (1,2,3,4,5). This cancer is the most common cancer in women, being the cancer with the highest incidence worldwide (6), with an estimated 35,001 new cases in 2023 in Spain (7). This is why a large number of patients receive systemic treatments that help surgery and radiotherapy to achieve a cure of over 80% in our environment, with a 5-year overall survival of 85.5% having been described (7).
These systemic oncological treatments generate well-known skin alterations such as xerosis, pruritus, erythema, pigmentation alterations, papulo-pustular eruptions, dermatosis, and others such as psoriasis (8,9,10,11).
The multimodal treatment of cancer finally becomes a long and hard process which, added to the fear of the diagnosis itself, and the physical changes as a consequence of these treatments, end up reducing the state of mind of the patients who suffer from it (12,13,14).
Self-care and the aesthetic improvement of the patient's appearance are the main reasons for this.
There are aesthetic treatments, such as hyaluronic acid 12mg/ml cross-linked (VYC-12L) in intradermal injection, that could improve the quality and aesthetics of the facial skin, which could help to improve the self-perception of patients who receive it, helping them to recover their self-confidence and improve their quality of life.
Research Question:
To objectively compare the skin quality of patients with previous history of breast cancer who have received and completed treatment with chemotherapy and/or monoclonal antibodies, before and after intradermal injection a cross-linked hyaluronic acid 12mg/ml (VYC-12L) in addition to self-esteem and quality of life.
Eligibility Criteria
Inclusion Criteria:
* Patients over 18 years old of age.
* Patients with a previous clinical history of having had breast cancer, who have received treatment and finished with chemotherapy and/or systemic monoclonal antibodies between the previous 1-18 months.
* Patients who have received and completed treatment with neoadjuvant or adjuvant chemotherapy and/or monoclonal antibodies to breast cancer surgery between 1-18 months prior to recruitment.
* Patients who, in the physician's opinion, can understand and properly answer study questionnaires.
* Patients to whom participation in this study was offered and they voluntarily decided to join and signed the informed consent.
Exclusion Criteria:
* Patients suffering from untreated epilepsy.
* Patients with a tendency to develop hypertrophic scars.
* Patients with known hypersensitivity to hyaluronic acid and/or gram-positive bacterial proteins since hyaluronic acid is produced by Streptococcus type bacteria.
* Patients with known hypersensitivity to lidocaine or amide-type local anesthetics.
* Patients suffering from porphyria.
* Pregnant or lactating women.
* Patients presenting inflammatory and/or infectious processes (acne, herpes, etc.).
* Patients should not be subjected to laser treatments, deep chemical peels or dermabrasion during the duration of the study.
* Patients with no history of psychiatric illnesses derived from the oncologic diagnosis such as confirmed major depression.
Source: ClinicalTrials.gov (NCT07917117). StuddyBuddy aggregates publicly available trial information.