Effect of DrugsPhase 2NCT03339882
Remifemin Preventing the Climacteric Symptoms in Breast Cancer
A Phase 2 study testing Remifemin in people with Effect of Drugs and Safety Issues, run by Zhejiang Cancer Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Effect of Drugs, Safety Issues
- What is being tested?
- Remifemin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 1 siteChina
- Study dates
- 4 Jan 2017to 30 Jan 2018
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Effect of Drugs, Safety Issues
- Being tested
- Remifemin
- Keywords
- remifemin, preventive effect, LHRH-a, breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RemifeminDrug
Also called cimicifuga racemosa, black cohosh
Remifemin 0.2g po bid*12 weeks at the beginning of the LHRH-a treatment
| Study group | Role | What they receive |
|---|---|---|
| Remifemin intervention | Experimental | Using Remifemin during LHRH-a treatment in breast cancer Receives: Drug: Remifemin |
| Control | No intervention | No intervention during LHRH-a treatment in breast cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 3 months after treatment
Secondary outcomes (1)
Disease free survival
Disease free survival rate in 2 years
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start4 Jan 2017
- Primary completion27 Nov 2017
- Study completion30 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Effect of DrugsStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xingfei Yu, Principal investigator, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03339882
- Sponsor's protocol ID
- ZJCH-RICH1
- Other IDs
- 2017ZA030
- Status last verified
- Jul 2018
- First submitted
- 15 Oct 2017
- Last updated
- 6 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30935866
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03339882
- Acronym / sponsor ID
- ZJCH-RICH1
- Conditions
- Effect of Drugs, Safety Issues
- Keywords
- remifemin, preventive effect, LHRH-a, breast cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Study start
- 4 Jan 2017 (actual)
- Primary completion
- 27 Nov 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 13 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Remifemin intervention | Experimental | Drug: RemifeminUsing Remifemin during LHRH-a treatment in breast cancer |
| Control | No intervention | –No intervention during LHRH-a treatment in breast cancer |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RemifeminAlso: cimicifuga racemosa, black cohoshRemifemin 0.2g po bid*12 weeks at the beginning of the LHRH-a treatment | Drug | Remifemin intervention |
Primary outcome
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).
1 secondary outcome
Disease free survival
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Derived from this study: PubMed 30935866Wang 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xingfei Yu principal investigator
Zhejiang Cancer Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Remifemin in people with Effect of Drugs and Safety Issues, run by Zhejiang Cancer Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Kupperman Item (KMI) (time frame: 3 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03339882, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jul 2018.