Remifemin Preventing the Climacteric Symptoms in Breast Cancer

Study Overview
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Brief Summary
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LHRH-a is an important hormone treatment in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a common clinical problem.

Detailed Description
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Ovarian function suppression (OFS) or protection has been studied widely in breast cancer. As an common drug in clinic, LHRH-a is an important method for OFS in breast cancer especially in high-risk hormone receptor-positive patients or hormone receptor-negative but needing ovarian function protecting. The climacteric symptoms caused by LHRH-a are often and prominent, which is a common clinical problem. Remifemin (cimicifuga racemosa / black cohosh) is effective in climacteric symptoms as a hormone replacement treatment, some research concluded that it is also safe in breast cancer patients who are postmenopausal or taking tamoxifen suffering from climacteric symptoms. While in China, more than 2/3 breast cancer patients are pre/peri-menopause, and some part of them should take OFS as an hormone treatment. OFS can cause sever climacteric symptoms in a short time. The investigators aim to estimate the effect and safety of Remifemin in climacteric symptoms caused by OFS in breast cancer.

Official Title
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The Effect of Remifemin in Preventing the Climacteric Symptoms Caused by LHRH-a Treatment in Breast Cancer: a Randomized II-stage Clinic Research

Conditions
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Effect of Drugs, Safety Issues

Intervention / Treatment
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* Drug: Remifemin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: provision of informed consent clinical stage I IIIC histologically proven invasive breast cancer women defined as premenopausal according to NCCN guideline plan to accept the LHRH-a as endocrine treatment or ovarian function protection Exclusion Criteria: clinical evidence of metastatic disease bilateral oophorectomy patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements patients who accepted anti-cancer treatment before previous hormonal therapy as adjuvant treatment for non-cancer disease patients unwilling to stop taking any drug known to affect sex hormonal status, or in whom it would be inappropriate to stop previous history of invasive malignancy within the last 5 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied treatment with a non-approved or experimental drug during 1 month before entry into the study history of bleeding diathesis (i.e., Disseminated intravascular coagulation, clotting factor deficiency), or long term anticoagulant therapy (other than antiplatelet therapy and low dose warfarin) leukopenia and/or thrombocytopenia history of ocular fundus diseases history of thromboembolic diseases history of osteoporotic fractures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Remifemin intervention<br>Using Remifemin during LHRH-a treatment in breast cancer | Drug: Remifemin<br>* Remifemin 0.2g po bid*12 weeks at the beginning of the LHRH-a treatment<br>* Other names: black cohosh;|
| No Intervention: Control<br>No intervention during LHRH-a treatment in breast cancer | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kupperman Item (KMI) | Scoring according to Kupperman item scale (Total: 0-48, the score higher the symptoms are severer) which includes of hot flash, sweat, insomnia, anxious, depressed, vertigo, fatigue, arthralgia, headache, palpitate (each item has a weighting coefficient according to four grade scores: no symptom *0, sometimes *1, always *2, influent life *3). | 3 months after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease free survival | Disease free survival rate in 2 years | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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LHRH-a, remifemin, preventive effect, breast cancer