Remifemin Preventing the Climacteric Symptoms in Breast Cancer

Phase 2

Completed

• Conditions: Effect of Drugs; Safety Issues
• Interventions: Drug: Remifemin

• Registration Number: NCT03339882
• Lead Sponsor: Zhejiang Cancer Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2017-01-04
• Study First Submitted: 2017-10-15
• Study First Submitted QC: 2017-11-07
• Study First Posted: 2017-11-13
• Primary Completion: 2017-11-27
• Study Completion: 2018-01-30
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-04
• Last Update Posted: 2018-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 85

Inclusion Criteria

1. provision of informed consent
2. clinical stage I~IIIC
3. histologically proven invasive breast cancer
4. women defined as premenopausal according to NCCN guideline
5. plan to accept the LHRH-a as endocrine treatment or ovarian function protection

Exclusion Criteria

1. clinical evidence of metastatic disease
2. bilateral oophorectomy
3. patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements
4. patients who accepted anti-cancer treatment before
5. previous hormonal therapy as adjuvant treatment for non-cancer disease
6. 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
7. treatment with a non-approved or experimental drug during 1 month before entry into the study
8. 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)
9. leukopenia and/or thrombocytopenia
10. history of ocular fundus diseases
11. history of thromboembolic diseases
12. history of osteoporotic fractures

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Remifemin intervention	Remifemin	Using Remifemin during LHRH-a treatment in breast cancer

Primary Outcome Measures

Name	Time	Method
Kupperman Item (KMI)	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).

Secondary Outcome Measures

Name	Time	Method
Disease free survival	2 years	Disease free survival rate in 2 years

Trial Locations

Locations (1)

Zhejiang Cancer Hospital; 🇨🇳 Hangzhou, Zhejiang, China