Remifemin Preventing the Climacteric Symptoms in Breast Cancer

• ClinicalTrials.gov Identifier: NCT03339882
• Recruitment Status: Completed
• First Posted: November 13, 2017
• Last Update Posted: July 6, 2018
• Sponsor: Zhejiang Cancer Hospital
• Information provided by (Responsible Party): Zhejiang Cancer Hospital

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Effect of Drugs; Safety Issues	Drug: Remifemin	Phase 2

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 Design

• 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

Arms and Interventions

Arm	Intervention/treatment
Experimental: Remifemin intervention; Using Remifemin during LHRH-a treatment in breast cancer	Drug: Remifemin; Remifemin 0.2g po bid*12 weeks at the beginning of the LHRH-a treatment; Other Names: cimicifuga racemosa; black cohosh
No Intervention: Control; No intervention during LHRH-a treatment in breast cancer

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. Disease free survival [ Time Frame: 2 years ]
   Disease free survival rate in 2 years

Eligibility Criteria

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

Criteria

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

Contacts and Locations

Locations

China, Zhejiang

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China, 310000

Sponsors and Collaborators

Zhejiang Cancer Hospital

Investigators

• Principal Investigator: Xingfei Yu; Zhejiang Cancer Hospital

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• 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
• 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

Keywords provided by Zhejiang Cancer Hospital:

remifemin; preventive effect; LHRH-a; breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases