Remifemin Preventing the Climacteric Symptoms in Breast Cancer
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03339882 |
Recruitment Status :
Completed
First Posted : November 13, 2017
Last Update Posted : July 6, 2018
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Condition or disease | Intervention/treatment | Phase |
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Effect of Drugs Safety Issues | Drug: Remifemin | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 85 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | The Effect of Remifemin in Preventing the Climacteric Symptoms Caused by LHRH-a Treatment in Breast Cancer: a Randomized II-stage Clinic Research |
Actual Study Start Date : | January 4, 2017 |
Actual Primary Completion Date : | November 27, 2017 |
Actual Study Completion Date : | January 30, 2018 |

Arm | Intervention/treatment |
---|---|
Experimental: Remifemin intervention
Using Remifemin during LHRH-a treatment in breast cancer
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Drug: Remifemin
Remifemin 0.2g po bid*12 weeks at the beginning of the LHRH-a treatment
Other Names:
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No Intervention: Control
No intervention during LHRH-a treatment in breast cancer
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- Kupperman Item (KMI) [ Time Frame: 3 months after treatment ]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).
- Disease free survival [ Time Frame: 2 years ]Disease free survival rate in 2 years

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Ages Eligible for Study: | 18 Years to 55 Years (Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339882
China, Zhejiang | |
Zhejiang Cancer Hospital | |
Hangzhou, Zhejiang, China, 310000 |
Principal Investigator: | Xingfei Yu | Zhejiang Cancer Hospital |
Responsible Party: | Zhejiang Cancer Hospital |
ClinicalTrials.gov Identifier: | NCT03339882 |
Other Study ID Numbers: |
ZJCH-RICH1 2017ZA030 ( Other Grant/Funding Number: Zhejiang Program of Traditional Chinese Medicine ) |
First Posted: | November 13, 2017 Key Record Dates |
Last Update Posted: | July 6, 2018 |
Last Verified: | July 2018 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Undecided |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
remifemin preventive effect LHRH-a breast cancer |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |