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

NCT06404775 | Not Yet Recruiting Phase 3 DMC

• 1 other identifier: SYSKY-2024-292-02
• Study Type: interventional
• Target: 456
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Mastalgia

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Subgroup mastalgia clinical response rate

  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

• 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

Study Arms (2)

external mastalgia-oil plus oral tamoxifen placebo

EXPERIMENTAL

Drug: mastalgia-oil, tamoxifen placebo

oral tamoxifen plus external mastalgia-oil placebo

ACTIVE COMPARATOR

Drug: mastalgia-oil placebo, tamoxifen

Interventions

mastalgia-oil, tamoxifen placebo DRUG

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

external mastalgia-oil plus oral tamoxifen placebo

mastalgia-oil placebo, tamoxifen DRUG

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

oral tamoxifen plus external mastalgia-oil placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510120, China

Location

Related 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.

  PMID: 20223665 BACKGROUND

MeSH Terms

Conditions

Mastodynia

Interventions

Tamoxifen

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Chang Gong, Prof

  Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chang Gong, Prof

CONTACT

02034070499; gchang@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 26, 2024
• First Posted: May 8, 2024
• Study Start: January 16, 2025
• Primary Completion (Estimated): January 16, 2029
• Study Completion (Estimated): May 16, 2030
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)