Improved Facial Skin Quality and Quality of Life After VYC-12L Treatment in Breast Cancer Survivors (ONCO AESTHETIC)
Improved Facial Skin Quality After Intradermal Injection of a Cross-linked 12mg/ml Hyaluronic Acid (VYC-12L) and Its Impact on Self-perception and Quality of Life in Patients With a Prior History of Breast Cancer Who Have Received and Completed Treatment With Chemotherapy and/or Systemic Monoclonal Antibodies.
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.
Přehled studie
Postavení
Intervence / Léčba
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Antonio J Lozano, Doctor
- Telefonní číslo: +34 ES 626980234
- E-mail: antoniojlozano@live.com
Studijní místa
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Murcia
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Murcia, Murcia, Španělsko, 30120
- Nábor
- Ctra.Madrid-Cartagena, s/n, El Palmar
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Kontakt:
- Antonio J Lozano, Doctor
- Telefonní číslo: +34 ES-626980234
- E-mail: antoniojlozano@live.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Patients with previous clinical history of having received and completed oncological treatment with chemotherapy and/or systemic monoclonal antibodies for breast cancer in the previous 1-18 months will be included.
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: COHORT
- Časové perspektivy: PROSPECTIVE
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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Intervention
intradermal injection |
12mg/ml cross-linked hyaluronic acid (VYC-12L) will be applied, distributed in 1 to 2 ml per side of the face in intradermal injection. |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Change in Skin Hydration and Elasticity From Baseline
Časové okno: Before the treatment and at 4 and 24 weeks after the initial treatment
|
To assess the improvement compared to baseline on the hydration and elasticity using a Multidermascope Microcaya MDS 1000 skin analyzer device. Scale of 0 to 99, higher scores mean a better outcome. |
Before the treatment and at 4 and 24 weeks after the initial treatment
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Skin quality based on investigator and subject assessments compared to baseline
Časové okno: At baseline, and on week 4 and 24 post study treatment
|
To assess the aesthetic improvement on skin quality based on investigator and subject assessments compared to baseline through an analysis with the VISIA device with 2D and 3D images at baseline using the FACE-Q Aesthetics - Psychological Function Scale . Scale of 0 to 100, higher scores mean a better outcome. |
At baseline, and on week 4 and 24 post study treatment
|
|
Change in Self-Esteem From Baseline
Časové okno: At baseline, and on week 4 and 24 post study treatment
|
To assess the overall improvement on self-esteem based on subjects assessments using the Rosemberg questionnaire (Rosenberg Self - Esteem Scale) at baseline. Scale of 0 to 40, higher scores mean a better outcome. |
At baseline, and on week 4 and 24 post study treatment
|
|
Change in Quality of Life From Baseline
Časové okno: At baseline, and on week 4 and 24 post study treatment
|
To assess the overall improvement on the quality of life based on subjects assessments using the EORTC QLQ-BR23 questionnaire quality of life specific to this patient population. Scale of 0 to 100, higher scores mean a better outcome. |
At baseline, and on week 4 and 24 post study treatment
|
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Global Aesthetic Improvement Based on GAIS Assessment
Časové okno: At week 4 and 24 post study treatment
|
To assess an overall aesthetic improvement based on investigator and subject assessments of at least a one-point improvement on the Global Aesthetic Improvement Scale (GAIS). Scale of 1 to 5, higher scores mean a worse outcome. |
At week 4 and 24 post study treatment
|
Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- 2023-11-6-HCUVA
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