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

November 26, 2024 updated by: Chang Gong, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
456

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510120
        • Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: external mastalgia-oil plus oral tamoxifen placebo
Drug: mastalgia-oil, tamoxifen placebo
external mastalgia-oil 1 ml/d per breast plus oral tamoxifen placebo 10mg/d for 3 consecutive menstrual cycles
Active Comparator: oral tamoxifen plus external mastalgia-oil placebo
Drug: mastalgia-oil placebo, tamoxifen
oral tamoxifen 10mg/d plus external mastalgia-oil placebo 1 ml/d per breast for 3 consecutive menstrual cycles

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mastalgia clinical response rate
Time Frame: 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.
Within 4 weeks after the end of the third treatment menstrual cycle
Safety (adverse events)
Time Frame: 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.
from signing the informed consent form until 4 weeks after the end of the third treatment menstrual cycle

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Subgroup mastalgia clinical response rate
Time Frame: 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
Within 4 weeks after the end of the third treatment menstrual cycle
Breast nodularity
Time Frame: 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.
Within 7 days before the first treatment and the end of each treatment menstrual cycle
Pharmacokinetics of mastodynia-oil
Time Frame: 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
Within 4 weeks after the end of the third treatment menstrual cycle
Changes in blood biochemical indicators
Time Frame: Within 4 weeks after the end of the third treatment menstrual cycle
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
Changes in blood metabolites
Time Frame: 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.
Within 4 weeks after the end of the third treatment menstrual cycle

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chang Gong, Prof, Breast Tumor Center, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 16, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 16, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 16, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 26, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 8, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 29, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 26, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SYSKY-2024-292-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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