JPRN-jRCTs031220435RecruitingUnknown
Hot Flash Treatment for Women with Hormone Receptor-Positive Breast Cancer: Safety and Efficacy of Venlafaxine - HOFLA-V
Bando Hiroko0 sites20 target enrollmentStarted: November 4, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Unknown
- Status
- Recruiting
- Sponsor
- Enrollment
- 20
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- >= 18age old to <= 60age old (—)
- Sex
- Female
Inclusion Criteria
- •(1) Patients aged between 18 and 60 at the time of consent
- •(2) Patients with stage 1-3C primary breast cancer
- •(3) Patients receiving tamoxifen for the adjuvant therapy with or without LH-RHagonists
- •(4) Patients with more than 14 hot flushes per week
- •(5) Eastern Cooperative Oncology Group Performance Status 0 or 1
- •(6) Patients who have agreed in writing to participate in this study after understanding this study an d who can adequately answer patient questionnaires.
Exclusion Criteria
- •(1) Patients diagnosed with depression
- •(2) Patients undergoing treatment for thyroid disease
- •(3) eGFR less than 15 mL/min or dialysis patients
- •(4) Patients with severe liver dysfunction: Bilirubin total is over 2mg/dl or AST or ALT is over 100 U/L
- •(5) Patients using the following drugs.
- •selective serotonin reuptake inhibitor:SSRI, Serotonin Noradrenaline Reuptake Inhibitor:SNRI(except for venlafaxine), Strong or moderate CYP2D6 inhibitor, CYP3A inhibitors and CYP3A inducers, gabapentinoids, MAO inhibitors
- •(6) Patients who had allergic reaction to venlafaxine
- •(7) Other patients that the research doctor deems inappropriate
Investigators
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