External Mastalgia-oil Versus Placebo in Premenopausal Women With Severe Mastalgia
- Conditions
- Mastalgia
- Interventions
- Drug: mastalgia-oilDrug: Mastalgia-oil placebo
- Registration Number
- NCT06966245
- Brief Summary
This is a single-center, double-blind, randomized clinical trial to explore the efficacy and safety of external mastalgia-oil versus placebo in premenopausal women with severe mastalgia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 190
- Premenopausal females aged ≥ 18 years old
- Pre-existing regular menstrual cycle (28 ± 5 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
- 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; essential oils or placebo 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description External mastalgia-oil mastalgia-oil - Mastalgia-oil placebo Mastalgia-oil placebo -
- Primary Outcome Measures
Name Time Method Mastalgia clinical response rate 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 ≥50% is considered a clinical response.
- Secondary Outcome Measures
Name Time Method Subgroup mastalgia clinical response rate Within 4 weeks after the end of the third treatment menstrual cycle Mastalgia clinical response rate in women with cyclical mastalgia; Mastalgia clinical response rate in women with non-cyclical mastalgia
Breast nodularity Within 7 days before the first treatment and the end of each treatment menstrual cycle 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.
Pharmacokinetics of mastodynia-oil Within 4 weeks after the end of the third treatment menstrual cycle Collection of blood samples for pharmacokinetic trough concentration-effect analysis of mastodynia-oil
Changes in blood metabolites Within 4 weeks after the end of the third treatment menstrual cycle Comparison of changes in blood metabolites before and after treatment and their correlation with primary endpoints using metabolomics.
Safety (AEs+SAEs) From signing the informed consent form until 28 days after completion of treatment Safety will be assessed according to the National Cancer Institute Common Terminology Criteria for Adverse Events (version 5.0).
Trial Locations
- Locations (1)
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
🇨🇳Guangzhou, China