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Remifemin Preventing the Climacteric Symptoms in Breast Cancer

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

Tracking Information
First Submitted Date  ICMJE October 15, 2017
First Posted Date  ICMJE November 13, 2017
Last Update Posted Date July 6, 2018
Actual Study Start Date  ICMJE January 4, 2017
Actual Primary Completion Date November 27, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2017)
Disease free survival [ Time Frame: 2 years ]
Disease free survival rate in 2 years
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Remifemin Preventing the Climacteric Symptoms in Breast Cancer
Official Title  ICMJE The Effect of Remifemin in Preventing the Climacteric Symptoms Caused by LHRH-a Treatment in Breast Cancer: a Randomized II-stage Clinic Research
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Effect of Drugs
  • Safety Issues
Intervention  ICMJE Drug: Remifemin
Remifemin 0.2g po bid*12 weeks at the beginning of the LHRH-a treatment
Other Names:
  • cimicifuga racemosa
  • black cohosh
Study Arms  ICMJE
  • Experimental: Remifemin intervention
    Using Remifemin during LHRH-a treatment in breast cancer
    Intervention: Drug: Remifemin
  • No Intervention: Control
    No intervention during LHRH-a treatment in breast cancer
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 3, 2018)
85
Original Estimated Enrollment  ICMJE
 (submitted: November 7, 2017)
80
Actual Study Completion Date  ICMJE January 30, 2018
Actual Primary Completion Date November 27, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03339882
Other Study ID Numbers  ICMJE ZJCH-RICH1
2017ZA030 ( Other Grant/Funding Number: Zhejiang Program of Traditional Chinese Medicine )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zhejiang Cancer Hospital
Study Sponsor  ICMJE Zhejiang Cancer Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Xingfei Yu Zhejiang Cancer Hospital
PRS Account Zhejiang Cancer Hospital
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP