A Randomized Prospective Clinical Trial to Evaluate Efficacy and Safety of LACUDY for Improving Vaginal Environment Among Breast Cancer Survivals Who Receive Anti-estrogen Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Change of Vaginal health index
研究概览
简要总结
Adjuvant hormone treatments for early breast cancer are associated with frequent bothersome side effects with major negative impact on patients' quality of life and treatment adherence. Patients most commonly report menopausal symptoms including vaginal dryness, vaginal bleeding, and dyspareunia. Even though previous studies have reported that estrogen topical agent relives these symptoms, non-hormonal therapy should be considered first due to concerns about the role of estrogen in breast cancer development. Therefore, this trial is planned to evaluate the efficacy and safety of LacuD (hyaluronic acid, lactic acid and alginate) in the vaginal environment of breast cancer patients receiving hormone therapy.
详细描述
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Registered subjects are 1:1 randomized using a random sequencing generator (www.random.org). Experimental group with 30 patients and Control group with 30 patinets.
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In the case of the experimental group, LACUDY 2mL is inserted twice a week for a month before going to bed for 4 weeks.
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Unpack the product and take it out.
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Remove the cap by turning it.
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Fit the nozzle to the end of the syringe and turn it to combine.
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Hold the syringe with the nozzle facing the vulva, insert it about 5-6 cm into the vagina, and then slowly press the tip of the push rod with patient's thumb to inject all the liquid in the syringe into the vagina.
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Slowly remove the syringe as the nozzle opens.
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It is recommended to wear a pad as the injected solution may flow out.
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In the case of the control group, they go about their daily lives without any treatment.
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Both the experimental group and the control group are instructed not to administer intravaginal suppositories or other drugs related to vaginal atrophy and sexual function improvement.
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A total of 2 questionnaires were conducted before and after treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Aged 20 to 60 years diagnosed with breast cancer
- •Receiving anti-hormonal therapy
- •Patients who subjectively complain of vaginal dryness
- •Patients without current psychiatric problems
- •Patients who can understand and respond to the contents of the questionnaire
- •Ability to provide informed consent
排除标准
- •Women under 19 and over 61
- •Pregnant woman
- •In case of recurrence or disease progression
- •Patients without sexual experience
- •Unable to provide informed consent
研究组 & 干预措施
Experimental
Breast cancer patient who treated with LACUD
干预措施: LACUDY (Drug)
结局指标
主要结局
Change of Vaginal health index
时间窗: Prior to administration, 1 month after LacuD treatment(2 times in total)
Female Sexual Function Index (FSFI) Quality of life assessed by Breast Version 4 (FACT-B)
次要结局
- Vaginal microbiome(Prior to administration, 1 month after LacuD treatment(2 times in total))
研究者
Gun Oh Chong
professor
Kyungpook National University Chilgok Hospital