External Mastalgia-oil Versus Oral Tamoxifen in Premenopausal Women with Severe Mastalgia: a Double-blind, Double-simulated, Positive-controlled Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 456
- 试验地点
- 1
- 主要终点
- Mastalgia clinical response rate
研究概览
简要总结
This is a single-center, double-blind, double-simulated, positive-controlled, randomized clinical trial to explore the efficacy and safety of external mastalgia-oil versus oral tamoxifen in premenopausal women with severe mastalgia.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal females aged ≥ 18 years old
- •Pre-existing regular menstrual cycle (28 ± 3 days) with mastalgia lasting for at least 6 consecutive menstrual cycles; with severe mastalgia [visual analog scale (VAS) score ≥ 4 for at least 7 days] and without chest wall pain in the baseline menstrual cycle (nonmedicated menstrual cycle)
- •With breast ultrasound: BI-RADS classification 1-3; if mammography is required: also BI-RADS classification 1-3
- •Willingness to follow up and complete required tests; ability to complete questionnaires independently or with assistance
- •Willingness to use effective contraception (vaginally administered estrogen and hormone-coated IUDs are permitted) prior to study entry, during study participation, and for three months after discontinuation of the drug; negative pregnancy test in females of childbearing potential
- •Requisite laboratory values:white blood cell count: ≥ 4.0 × 10^9/L, absolute neutrophil count: ≥ 2 × 10^9/L, platelet count: ≥ 100 × 10^9/L; hemoglobin: ≥ 110 g/L; aspartate aminotransferase and alanine aminotransferase: ≤ upper limit of normal, alkaline phosphatase: ≤ upper limit of normal, blood total bilirubin: ≤ upper limit of normal; serum creatinine and blood urea nitrogen: ≤ upper limit of normal
排除标准
- •With suspected breast disease (e.g., mastitis, malignant breast tumor) other than breast pain or benign breast cysts, or with other malignant tumors
- •Use of hormonal medications (e.g., oral contraceptives, glucocorticoids, etc.), sex hormone modulators (SERMS, AIs, SERDs, etc.), B vitamins, essential oils, nonsteroidal anti-inflammatory drugs, or higher pain relievers in the past 3 months; use of tamoxifen or analogs in the past 6 months
- •Prior history of breast surgery (including minimally invasive surgery), history of malignancy, or history of thromboembolism within the last 5 years (history of varicose veins and superficial phlebitis allowed)
- •Smokers; tamoxifen or essential oils systemic/skin sensitization
- •With serious primary diseases of the heart, liver, kidneys and hematopoietic system, or mental illness, etc.
- •Accompanied by skin damage on the breast that destroys the stratum corneum (e.g., eczema, ulcers)
- •Serious or uncontrolled infections that may interfere with study treatment or assessment of study results, including but not limited to active hepatitis viral infection, human immunodeficiency virus antibody positivity, syphilis spirochete antibody positivity with evidence of active infection, and pulmonary infections
- •Subjects who are breastfeeding or pregnant at the time of screening (of childbearing age and with serum human chorionic gonadotropin test results higher than the reference value); subjects of childbearing age who have had unprotected sex with a heterosexual partner within 2 weeks prior to the screening; subjects of childbearing age who are planning to prepare for conception, become pregnant, breastfeed, or donate their eggs during the test period or within 3 months of the end of the test; and those with implanted breasts
- •Decrease in total breast pain score by more than 25% during the placebo lead-in cycle. These patients will not receive subsequent randomization and treatment.
研究组 & 干预措施
external mastalgia-oil plus oral tamoxifen placebo
干预措施: mastalgia-oil, tamoxifen placebo (Drug)
oral tamoxifen plus external mastalgia-oil placebo
干预措施: mastalgia-oil placebo, tamoxifen (Drug)
结局指标
主要结局
Mastalgia clinical response rate
时间窗: Within 4 weeks after the end of the third treatment menstrual cycle
The recruited patients with mastalgia will be asked to record their symptoms of breast pain using a daily VAS breast pain chart, and the sum of the daily VAS within a menstrual cycle is considered the breast pain score (BPS). Effective rate (%)= \[BPS (P) - BPS (T3)\]/BPS (P)\*100%, where BPS (P) indicates BPS of the placebo lead-in cycle and BPS (T3) indicates BPS at the end of the third treatment cycle. An effective rate of more than 50% is considered a clinical response.
Safety (adverse events)
时间窗: from signing the informed consent form until 4 weeks after the end of the third treatment menstrual cycle
Total incidence of the following adverse events: hot flashes + leukorrhea + menorrhagia + nausea + headache + skin reactions. Adverse events will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).Each patient will be counted only once for the above adverse events experienced.
次要结局
- Subgroup mastalgia clinical response rate(Within 4 weeks after the end of the third treatment menstrual cycle)
- Pharmacokinetics of mastodynia-oil(Within 4 weeks after the end of the third treatment menstrual cycle)
- Changes in blood biochemical indicators(Within 4 weeks after the end of the third treatment menstrual cycle)
- Changes in blood metabolites(Within 4 weeks after the end of the third treatment menstrual cycle)
- Breast nodularity(Within 7 days before the first treatment and the end of each treatment menstrual cycle)
研究者
Chang Gong
Clinical Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University