Remifemin Preventing the Climacteric Symptoms in Breast Cancer

Safety Issues Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339882
• Other study ID #: ZJCH-RICH1
• Secondary ID: 2017ZA030
• Status: Completed
• Phase: Phase 2
• Start date: January 4, 2017
• Est. completion date: January 30, 2018

Study information

• Verified date: July 2018
• Source: Zhejiang Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: January 30, 2018
• Est. primary completion date: November 27, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Effect of Drugs
• Safety Issues

Intervention

Drug:
• Remifemin
Remifemin 0.2g po bid*12 weeks at the beginning of the LHRH-a treatment

Locations

Country	Name	City	State
China	Zhejiang Cancer Hospital	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Zhejiang Cancer Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Disease free survival	Disease free survival rate in 2 years	2 years