Effect of venlafaxine for hot flash

JRCT ID: jRCTs031220435

Registered date:04/11/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: breast cancer
• Date of first enrollment: 13/12/2022
• Target sample size: 20
• Study type: Interventional

Intervention(s)

Administration of venlafaxine once a day for 4 weeks.
At the first week, patients record hot flash diary .
At the second week, venlafaxine is administrated in dose of 37.5mg once a day.
At the third week, increasing to 75 mg/dose once a day if the effect is insufficient.

Outcome(s)

• Primary Outcome: Rate of change in hot flash score from baseline to week 4 of venlafaxine administration

Secondary Outcome

(1) QOL assessment by Hot Flash Related Daily Interference Scale (HFRDIS)
(2) QOL assessment by EORTC QLQ-C30
(3) Depression assessment by Hospital Anxiety and Depression Scale (HADS)
(4) Sleeping disorder assessment by Pittsburgh Sleep Quality Index(PSQI)
(5) Plasma levels of tamoxifen, N-desmethyl tamoxifen, endoxiefen, 4-Hydroxytamoxifen
(6) Association between hot flash score and plasma levels of venlafaxine
(7) Association between cytochrome P450 2D6 (CYP2D6) genetic polymorphism and plasma levels of venlafaxine
(8) Completion rate for venlafaxine
(9) Continuity status of venlafaxine after the study
(10) Questionnaire survey about venlafaxine
(11) Adverse events of CTCAE ver 5.0 grading scale

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 60age old
• Gender: Female

Include 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.

Exclude 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

Related Information

• Primary Sponsor: Bando Hiroko
• Source(s) of Monetary Support: University of Tsukuba Hospital