Evaluation of Quality of Life After Facial Hyaluroic Acid Injections Following Treatment for Breast Cancer.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 22
- 主要终点
- Facial appearance following facial hyaluronic acid injection following breast cancer treatment.
研究概览
简要总结
Breast cancer, the most common cancer in women, is increasingly managed as a chronic disease thanks to therapeutic advances. However, treatments such as chemotherapy and hormonotherapy often induce premature menopause in younger women, leading to skin aging, atrophy, and distressing symptoms that negatively affect quality of life. These cutaneous effects are frequently overlooked despite their psychological and social impact. Hyaluronic acid injections, already well established in aesthetic and reconstructive medicine, may offer a safe, minimally invasive option to restore skin quality, improve self-esteem, and enhance overall well-being in breast cancer survivors. This study aims to assess their efficacy and safety in this specific population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 18 years old and ≤ 50 years old.
- •Non-menopausal status at time of diagnosis of breast cancer (self-reporting).
- •Patient with breast cancer (uni or bilateral):
- •treated at the Institut Bergonié by chemotherapy (+/- targeted/immunotherapy) and surgical treatment (conservative or not) and/or hormone therapy and/or radiotherapy
- •who completed their treatment at least 6 months ago including end of treatment with Herceptin but with the exception for ongoing hormone therapy
- •in complete remission
- •Non-immunosuppressed patient.
- •Voluntarily signed and dated written informed consent prior to any study specific procedure.
- •Patient affiliated to a social security in compliance with Article 1121-11 of the French Public Health Code.
排除标准
- •Patients with a history of or declared autoimmune disease or immune system deficiency or undergoing immunosuppressive treatment. A 6-month washout is required.
- •Patients undergoing or planning to undergo peeling treatment or laser/ultrasound-based or botox treatment or hyaluronic acid injections during the study or having had one of these treatments in the 6 months preceding the study.
- •Patients showing cutaneous disorders, inflammation or infection (acne, herpes labialis, scars…) at the treatment site or near to this site.
- •Patients having a known hypersensibility to lidocaine and/or amide local anaesthetic agents or hyaluronic acid and/or proteins from gram-positive bacteria, or with a history of severe allergy or anaphylactic shock.
- •Patients with a history of streptococcal disease (recurrent sore throat, rheumatic fever)
- •Patients with autoimmune or cardiac diseases (i.e. heart conduction disorders) and/or undergoing treatment for heart diseases (beta-blockers).
- •Patients with hepatocellular insufficiency and/or undergoing treatment for liver disease.
- •Patients suffering from epilepsy not controlled by a treatment or porphyria.
- •Patients with a tendency to develop hypertrophic scars.
- •Patients with severe, ongoing and/or uncontrolled disease that may pose a health risk to the patient during the study and/or may have an impact on the study assessments.
- •Patients receiving or planning to receive high dose Vitamin E, aspirin, anti-inflammatories, or anti-coagulant during the week preceding each injection
- •Patients receiving any long-term medical treatment or any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the patient at undue risk.
- •Patients under guardianship/tutorship.
- •Pregnant women or breastfeeding mothers.
研究组 & 干预措施
Hyaluronic acid injection
干预措施: Inject of hyaluronic acid in the face (Device)
结局指标
主要结局
Facial appearance following facial hyaluronic acid injection following breast cancer treatment.
时间窗: 3 months
Facial appearance will be measured using the score obtained at the "facial appearance" subdomain of the FACE-Q Aesthetics Questionnaire. The score ranges from 0 (worst outcome) to 100 (best outcome).
Health-related quality of life followig facial hyaluronic acid injection following breast cancer treatment.
时间窗: 3 months
Health-related quality of life will be measured using the score obtained at the "health-related quality of life" subdomain of the FACE-Q Aesthetics Questionnaire. The score ranges from 0 (worst outcome) to 100 (best outcome).
Adverse effects following facial hyaluronic acid injection following breast cancer treatment.
时间窗: 3 months
Adverse effects will be measured using the score obtained at the "Adverse effects" subdomain of the FACE-Q Aesthetics Questionnaire. The score ranges from 0 (worst outcome) to 100 (best outcome).
次要结局
未报告次要终点