Desvenlafaxine for the Treatment of Hot Flashes in Women With Breast Cancer Taking Tamoxifen: a Randomized, Double-blind, Placebo-controlled Study
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 59
- 试验地点
- 3
- 主要终点
- Reduction rate of hot flashes symptom score
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Desvenlafaxine succinate 100mg (Drug)
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.
干预措施: Desvenlafaxine succinate 50mg (Drug)
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.
干预措施: Placebo (Drug)
结局指标
主要结局
Reduction rate of hot flashes symptom score
时间窗: 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.
次要结局
- Clinical impression state and change(Week 1, Week 2, Week 5)
- Anxiety(Baseline, Week 2, Week 5)
- Manic or Hypomanic symptoms.(Baseline, Week 2, Week 5)
- Sleep quality(Baseline, Week 2, Week 5)
- Circadian misalignment(Baseline, Week 2, Week 5)
- Fatigue(Baseline, Week 2, Week 5)
- Hormonal level(Week 2)
- Genetic polymorphism(Week 2)
- Body image(Baseline)
- Resilience(Baseline)
- Peripheral neuropathy(Week 1, Week 2, Week 5)
- Chonotype(Baseline)
- Illness perception(Baseline)
- Depression(Baseline, Week 2, Week 5)
- Quality of life(Baseline, Week 2, Week 5)
- Beliefs about medicines(Baseline)
- Social support(Baseline)