ClinicalTrials.gov
ClinicalTrials.gov Menu

Remifemin Preventing the Climacteric Symptoms in Breast Cancer

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03339882
Recruitment Status : Recruiting
First Posted : November 13, 2017
Last Update Posted : November 13, 2017
Sponsor:
Information provided by (Responsible Party):
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.

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 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 : October 30, 2016
Estimated Primary Completion Date : February 27, 2018
Estimated Study Completion Date : October 30, 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Remifemin intervention
Using Remifemin during LHRH-a treatment in breast cancer
Drug: Remifemin
Remifemin 0.28g 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



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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Information from the National Library of Medicine

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


Contacts
Contact: Xingfei Yu, MD yuxf1177@zjcc.org.cn
Contact: Hongjian Yang, MD yanghj@zjcc.org.cn

Locations
China, Zhejiang
Zhejiang Cancer Hospital Recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Xingfei Yu, MD       yuxf1177@zjcc.org.cn   
Contact: Hongjian Yang, MD       yanghj@zjcc.org.cn   
Principal Investigator: Xingfei Yu, MD         
Sponsors and Collaborators
Zhejiang Cancer Hospital
Investigators
Principal Investigator: Xingfei Yu Zhejiang Cancer Hospital

Responsible Party: Zhejiang Cancer Hospital
ClinicalTrials.gov Identifier: NCT03339882     History of Changes
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: November 13, 2017
Last Verified: October 2017
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