Clincosm LogoSign in Get a demo

Remifemin Preventing the Climacteric Symptoms in Breast Cancer

Sponsor
Zhejiang Cancer Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03339882
Collaborator
(none)
85
Enrollment
1
Location
2
Arms
12.8
Actual Duration (Months)
6.6
Patients Per Site Per Month

Study Details

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
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
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 :
Jan 4, 2017
Actual Primary Completion Date :
Nov 27, 2017
Actual Study Completion Date :
Jan 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) [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 [2 years]

      Disease free survival rate in 2 years

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 55 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 Zhejiang Cancer Hospital Hangzhou Zhejiang China 310000

    Sponsors and Collaborators

    • Zhejiang Cancer Hospital

    Investigators

    • Principal Investigator: Xingfei Yu, Zhejiang Cancer Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Zhejiang Cancer Hospital
    ClinicalTrials.gov Identifier:
    NCT03339882
    Other Study ID Numbers:
    • ZJCH-RICH1
    • 2017ZA030
    First Posted:
    Nov 13, 2017
    Last Update Posted:
    Jul 6, 2018
    Last Verified:
    Jul 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    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

    Study Results

    No Results Posted as of Jul 6, 2018