External Mastalgia-oil Versus Oral Tamoxifen in Premenopausal Women With Severe Mastalgia

Mastalgia Clinical Trial

Official title:

External Mastalgia-oil Versus Oral Tamoxifen in Premenopausal Women With Severe Mastalgia: a Double-blind, Double-simulated, Positive-controlled Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06404775
• Other study ID #: SYSKY-2024-292-02
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: May 16, 2024
• Est. completion date: May 16, 2029

Study information

• Verified date: May 2024
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Chang Gong, Prof
• Phone: 02034070499
• Email: gchang[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 456
• Est. completion date: May 16, 2029
• Est. primary completion date: May 16, 2028
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Mastalgia
• Mastodynia

Intervention

Drug:
• mastalgia-oil, tamoxifen placebo
external mastalgia-oil 1 ml/d per breast plus oral tamoxifen placebo 10mg/d for 3 consecutive menstrual cycles
• mastalgia-oil placebo, tamoxifen
oral tamoxifen 10mg/d plus external mastalgia-oil placebo 1 ml/d per breast for 3 consecutive menstrual cycles

Locations

Country	Name	City	State
China	Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

Kumar S, Rai R, Das V, Kumar S, Dwivedi V, Agrawal GG. Visual analogue scale for assessing breast nodularity in non-discrete lumpy breasts: the Lucknow-Cardiff breast nodularity scale. Breast. 2010 Jun;19(3):238-42. doi: 10.1016/j.breast.2010.02.002. Epub 2010 Mar 11. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Within 4 weeks after the end of the third treatment menstrual cycle
Primary	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.	from signing the informed consent form until 4 weeks after the end of the third treatment menstrual cycle
Secondary	Subgroup mastalgia clinical response rate	Mastalgia clinical response rate in women with cyclical mastalgia; Mastalgia clinical response rate in women with non-cyclical mastalgia	Within 4 weeks after the end of the third treatment menstrual cycle
Secondary	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.	Within 7 days before the first treatment and the end of each treatment menstrual cycle
Secondary	Pharmacokinetics of mastodynia-oil	Collection of blood samples for pharmacokinetic trough concentration-effect analysis of mastodynia-oil	Within 4 weeks after the end of the third treatment menstrual cycle
Secondary	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.	Within 4 weeks after the end of the third treatment menstrual cycle
Secondary	Changes in blood metabolites	Comparison of changes in blood metabolites before and after treatment and their correlation with primary endpoints using metabolomics.	Within 4 weeks after the end of the third treatment menstrual cycle