Clinical trial · Interventional
Remifemin Preventing the Climacteric Symptoms in Breast Cancer
The Effect of Remifemin in Preventing the Climacteric Symptoms Caused by LHRH-a Treatment in Breast Cancer: a Randomized II-stage Clinic Research
NCT03339882CI-TRIAL-00033650completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Effect of Drugs | — | UNRESOLVED | — |
| Safety Issues | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remifemin | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Remifemin intervention
- description
- Using Remifemin during LHRH-a treatment in breast cancer
- interventionNames
- Drug: Remifemin
- type
- NO_INTERVENTION
- label
- Control
- description
- No intervention during LHRH-a treatment in breast cancer
Primary outcomes (1)
- measure
- Kupperman Item (KMI)
- timeFrame
- 3 months after treatment
- 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).
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDWang 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. PMID 30935866