Desvenlafaxine for Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen
- Conditions
- Hot FlashesBreast Neoplasms
- Interventions
- Registration Number
- NCT02819921
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
This study is a randomized, placebo-controlled study of desvenlafaxine versus placebo. The purpose of this study is to determine if desvenlafaxine was effective in decreasing the frequency and severity of hot flashes in breast cancer patients taking tamoxifen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 59
i. Women age 18 years and older with localized breast cancer. Histologic documentation of atypical ductal hyperplasia, ductal carcinoma in situ (DCIS), lobular carcinoma in situ (LCIS), or invasive adenocarcinoma of the breast stages I-III A.
ii. Current daily tamoxifen use (≥ 6 days/week). Any planned surgery, adjuvant chemotherapy or radiation must have been completed.
iii. History of bothersome hot flushes: ≥ 14 hot flushes/week (average ≥ 2 hot flushes/day), sufficiently severe that intervention is desired. Participants must have had bothersome hot flushes for at least one month prior to enrollment.
i. Women who is pregnant or breast feeding, or who has a history of seizure disorder or hepatic or renal insufficiency ii. Concurrent systemic hormone replacement therapy (estrogen, progestational agents, androgens) or use of corticosteroids iii. Concurrent use of other antidepressants, anxiolytics and antipsychotics, gabapentin, pregabalin and clonidine for treatment of hot flushes or depression.
iv. Presense or past history of severe psychiatric symptoms such as hallucinations and delusions, manic episodes, or high suicide risk.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Desvenlafaxine succinate 100mg Desvenlafaxine succinate 100mg Titration with 50 mg Desvenlafaxine succinate tablet once daily for 1 week, then 2 tablets of 50mg Desvenlafaxine succinate tablet once daily for 3 weeks, then taper with 50 mg Desvenlafaxine succinate tablet once daily for 3 days. Placebo Placebo 50 mg placebo tablet once daily for 1 week, then 2 tablets of 50mg placebo tablet once daily for 3 weeks, then 50 mg placebo tablet once daily for 3 days. Desvenlafaxine succinate 50mg Desvenlafaxine succinate 50mg 50 mg Desvenlafaxine succinate tablet once daily for 1 week, then 1 tablets of 50mg Desvenlafaxine succinate tablet and 1 tablet of 50mg placebo tablet once daily for 3 weeks, then 50mg placebo tablet once daily for 3 days.
- Primary Outcome Measures
Name Time Method Reduction rate of hot flashes symptom score From baseline to Week 5 (Intervention is started from Week 1) Participants would complete self -report daily diary on which they record the number and severities (1 - 4 points) of hot flashes from baseline to week 5. Each symptom severities are multiplied by the numbers of symptoms to determine the daily hot flashes symptom score. The mean of daily hot flashes symptom score of one week is calculated and regared as a hot flashes symptom score for the week. The efficacy of Desvenlafaxine is assessed by comparing the reduction rate of weekly hot flashes symptom score (= hot flashes symptom score at week 5 - hot flashes symptom score at baseline / hot flashes symptom score of baseline) for each group.
- Secondary Outcome Measures
Name Time Method Clinical impression state and change Week 1, Week 2, Week 5 Clinical global impression (CGI) would be used to assess clinical impression state and change.
Anxiety Baseline, Week 2, Week 5 Generalized anxiety disorder-7 (GAD-7) would be used to assess anxiety.
Manic or Hypomanic symptoms. Baseline, Week 2, Week 5 Mood disorder questionnaire (MDQ) would be used to assess manic or hypomanic symptoms.
Sleep quality Baseline, Week 2, Week 5 Pittsburgh sleep quality index (PSQI) would be used to assess sleep quality.
Circadian misalignment Baseline, Week 2, Week 5 Munich Chronotype Questionnaire (MCTQ) would be used to assess circadian misalignment.
Fatigue Baseline, Week 2, Week 5 Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-fatigue) would be used to assess fatigue.
Hormonal level Week 2 Serum estradiol, follicle-stimulating hormone (FSH) and anti-Müllerian hormone (AMH) levels would be used to examine pathophysiological mechanisms associated with the presence of hot flashes, mood status and desvenlafaxine treatment.
Genetic polymorphism Week 2 estrogen receptors (ESR1 PvuII; rs#2234693 and XbaI; rs#9340799 and ESR2-02; rs#4986938) and serotonin transporter gene (SLC6A4; rs#11080121) would be used to examine pathophysiological mechanisms associated with the presence of hot flashes, mood status and desvenlafaxine treatment.
Body image Baseline Body Image Scale (BIS) would be used to assess body image.
Peripheral neuropathy Week 1, Week 2, Week 5 European Organization for Research and Treatment of Cancer - Quality of Life Questionnaire - Chemotherapy-Induced Peripheral Neuropathy(EORTC-QLQ-CIPN-20) would be used to assess peripheral neuropathy.
Chonotype Baseline Morningness-Eveningness questionnaire (MEQ) would be used to assess chronotype.
Illness perception Baseline Brief Illness Perception Questionnaire (BIPQ) would be used to assess illness perception.
Depression Baseline, Week 2, Week 5 Patient health questionnaire (PHQ-9) would be used to assess mood status.
Quality of life Baseline, Week 2, Week 5 Functional Assessment of Cancer Therapy-Breast (FACT-B) would be used to assess quality of life.
Beliefs about medicines Baseline Beliefs about Medicines Questionnaire (BMQ) would be used to assess beliefs about medicines.
Social support Baseline Multidimensional Scale of Perceived Social Support (MSPSS) would be used to assess social supports.
Resilience Baseline Connor-Davidson Resilience Scale (CDRS) would be used to assess resilience.
Trial Locations
- Locations (3)
Seoul National University Bundang Hospital
🇰🇷Seongnam, Gyeonggi-do, Korea, Republic of
National Cancer Center
🇰🇷Goyang, Gyeonggi-do, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of