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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
456
external mastalgia-oil 1 ml/d per breast plus oral tamoxifen placebo 10mg/d for 3 consecutive menstrual cycles
oral tamoxifen 10mg/d plus external mastalgia-oil placebo 1 ml/d per breast for 3 consecutive menstrual cycles
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, China
Mastalgia clinical response rate
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.
Time frame: Within 4 weeks after the end of the third treatment menstrual cycle
Safety (adverse events)
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.
Time frame: from signing the informed consent form until 4 weeks after the end of the third treatment menstrual cycle
Subgroup mastalgia clinical response rate
Mastalgia clinical response rate in women with cyclical mastalgia; Mastalgia clinical response rate in women with non-cyclical mastalgia
Time frame: Within 4 weeks after the end of the third treatment menstrual cycle
Breast nodularity
Breast nodularity will be assessed according to the Lucknow-Cardiff breast nodularity scale.The above breast nodularity scale is a 5-point ordinal scale depicting increasing order of nodularity in upper outer quadrants of the breasts. Grade-0 depicts a smooth textured breast with extreme extent of normalcy and grade-4 the maximum nodularity.
Time frame: Within 7 days before the first treatment and the end of each treatment menstrual cycle
Pharmacokinetics of mastodynia-oil
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Collection of blood samples for pharmacokinetic trough concentration-effect analysis of mastodynia-oil
Time frame: Within 4 weeks after the end of the third treatment menstrual cycle
Changes in blood biochemical indicators
Tamoxifen-specific indicators: estradiol, progesterone, et al. and their correlation with the primary endpoints were detected in blood before and after treatment using ELISA.
Time frame: Within 4 weeks after the end of the third treatment menstrual cycle
Changes in blood metabolites
Comparison of changes in blood metabolites before and after treatment and their correlation with primary endpoints using metabolomics.
Time frame: Within 4 weeks after the end of the third treatment menstrual cycle