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| ID | Type | Description | Link |
|---|---|---|---|
| 2017ZA030 | Other Grant/Funding Number | Zhejiang Program of Traditional Chinese Medicine |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remifemin intervention | Experimental | Using Remifemin during LHRH-a treatment in breast cancer |
|
| Control | No Intervention | No intervention during LHRH-a treatment in breast cancer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remifemin | Drug | Remifemin 0.2g po bid*12 weeks at the beginning of the LHRH-a treatment |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival | Disease free survival rate in 2 years | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xingfei Yu | Zhejiang Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang Cancer Hospital | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30935866 | Derived | Wang C, Huang Q, Liang CL, Zhang YW, Deng DH, Yu Y, Chen DB, Yang HJ, Yu XF. Effect of cimicifuga racemosa on menopausal syndrome caused by LHRH-a in breast cancer. J Ethnopharmacol. 2019 Jun 28;238:111840. doi: 10.1016/j.jep.2019.111840. Epub 2019 Mar 29. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Jun 1, 2019 | |
| Reset | Jul 26, 2019 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 1, 2019 | Jul 26, 2019 |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C073419 | Remifemin |
| C000713173 | black cohosh root extract |
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| D017437 |
| Skin and Connective Tissue Diseases |