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Remifemin Preventing the Climacteric Symptoms in Breast Cancer

Primary Purpose

Effect of Drugs, Safety Issues

Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Remifemin
Sponsored by
Zhejiang Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Effect of Drugs focused on measuring remifemin, preventive effect, LHRH-a, breast cancer

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Zhejiang Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Remifemin intervention

Control

Arm Description

Using Remifemin during LHRH-a treatment in breast cancer

No intervention during LHRH-a treatment in breast cancer

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Disease free survival
Disease free survival rate in 2 years

Full Information

First Posted
October 15, 2017
Last Updated
July 4, 2018
Sponsor
Zhejiang Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03339882
Brief Title
Remifemin Preventing the Climacteric Symptoms in Breast Cancer
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
January 4, 2017 (Actual)
Primary Completion Date
November 27, 2017 (Actual)
Study Completion Date
January 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhejiang Cancer Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Effect of Drugs, Safety Issues
Keywords
remifemin, preventive effect, LHRH-a, breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
85 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Remifemin intervention
Arm Type
Experimental
Arm Description
Using Remifemin during LHRH-a treatment in breast cancer
Arm Title
Control
Arm Type
No Intervention
Arm Description
No intervention during LHRH-a treatment in breast cancer
Intervention Type
Drug
Intervention Name(s)
Remifemin
Other Intervention Name(s)
cimicifuga racemosa, black cohosh
Intervention Description
Remifemin 0.2g po bid*12 weeks at the beginning of the LHRH-a treatment
Primary Outcome Measure Information:
Title
Kupperman Item (KMI)
Description
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).
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
Disease free survival
Description
Disease free survival rate in 2 years
Time Frame
2 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: provision of informed consent clinical stage I~IIIC histologically proven invasive breast cancer women defined as premenopausal according to NCCN guideline plan to accept the LHRH-a as endocrine treatment or ovarian function protection Exclusion Criteria: clinical evidence of metastatic disease bilateral oophorectomy patients who, for whatever reason (e.g., confusion, infirmity, alcoholism), are unlikely to comply with trial requirements patients who accepted anti-cancer treatment before previous hormonal therapy as adjuvant treatment for non-cancer disease 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 treatment with a non-approved or experimental drug during 1 month before entry into the study 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) leukopenia and/or thrombocytopenia history of ocular fundus diseases history of thromboembolic diseases history of osteoporotic fractures
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xingfei Yu
Organizational Affiliation
Zhejiang Cancer Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhejiang Cancer Hospital
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30935866
Citation
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.
Results Reference
derived

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Remifemin Preventing the Climacteric Symptoms in Breast Cancer

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