VENLAFAXINE FOR HOT FLASHES FOLLOWING BREAST CANCER

潮热是乳腺癌女性报告的最严重和第四常见的更年期症状。超过65%的人会受到潮热的影响，59%的人认为潮热症状很严重，44%的人说他们对这种症状感到非常痛苦。尽管与这种症状相关的高患病率、严重性和痛苦，但管理乳腺癌女性潮热的科学基础是有限的。这项随机、双盲、安慰剂对照的交叉试验考察了缓释文拉法辛(37.5 mg，po，qd)治疗乳腺癌治疗后女性潮热的有效性和毒性。文拉法辛是一种苯乙胺衍生物，能有效地抑制神经元5-羟色胺和去甲肾上腺素的再摄取，并微弱地抑制多巴胺的再摄取。这个项目的第二个目标是检查潮热对心理、行为和身体结果的影响。本研究基于Wickham症状管理模型，该模型描述了症状、症状管理策略和症状管理结果之间的相互关系。手术、放疗和/或化疗完成后至少1个月、服用他莫昔芬(如果处方)至少6周的参与者(n=80)将完成为期2周的基线潮热评估，并被随机分配到交叉试验的一组。在第一个为期6周的研究结束时，参与者将交叉到另一个研究小组，再进行6周的研究。要评估的结果包括干预的有效性(潮热频率、严重程度、痛苦和程度)、干预的毒性(主观偏好、副作用)、心理结果(情绪障碍)、行为结果(生活质量、对日常活动的干扰)和身体结果(疲劳和睡眠障碍)。每天将使用主观的、前瞻性的日记方法测量潮热，每周使用客观最先进的24小时生理监测胸骨皮肤电导。其他结果将每周衡量一次。每周将使用药物泡罩包装卡对干预/安慰剂的依从性进行评估。结果评估的时间根据生理监测设备的限制和预期的治疗效果时间而定。摘要统计(即平均值、斜率、最大响应、范围、比例、可实现的差异)将被用于有效地将设计减少到2×2交叉，并将相应地分析数据(即，t检验、线性回归、GEE、混合模型)。研究结果将为乳腺癌治疗后女性潮热处理的科学基础做出重大贡献。

Hot flashes are the most severe and fourth most prevalent menopausal symptom reported by women with breast cancer. Hot flashes affect over 65 percent of this population, with 59 percent rating the symptom as severe and 44 percent reporting they are extremely distressed by the symptom. Despite the high prevalence, severity and distress associated with this symptom, the scientific basis for managing hot flashes in women with breast cancer is limited. This randomized, double-blind, placebo-controlled crossover trial examines the effectiveness and toxicity of sustained release venlafaxine hydrochloride (37.5 mg po qd) on hot flashes in women following treatment for breast cancer. Venlafaxine is a phenylethylamine derivative that potently inhibits the reuptake of neuronal serotonin and norepinephrine and weakly inhibits the reuptake of dopamine. A secondary aim of this project is to examine the impact of hot flashes on psychological, behavioral, and physical outcomes. This study is based on the Wickham Symptom Management Model which depicts interrelationships between symptoms, symptom management strategies, and symptom management outcomes. Participants (n = 80) who are at least one month post-completion of surgery, radiation, and/or chemotherapy and who have been on tamoxifen (if prescribed) for at least 6 weeks will complete a 2-week baseline hot flash assessment and be randomized to one arm of the crossover trial. At the end of the first 6-week arm, participants will crossover to the opposite study arm for an additional 6 weeks. Outcomes to be assessed include effectiveness of the intervention (hot flash frequency, severity, distress and magnitude), toxicity of the intervention (subjective preference, side effects), psychological outcomes (mood disturbance), behavioral outcomes (quality of life, interference with daily activities) and physical outcomes (fatigue and sleep disturbance). Hot flashes will be measured daily, using a subjective, prospective diary methodology, and weekly, using objective state-of-the art 24-hour physiological monitoring of sternal skin conductance. Other outcomes will be measured weekly. Compliance with the intervention/placebo will be assessed weekly using medication blister pack cards. Timing of outcome assessments is based on limitations of the physiological monitoring device and expected timing of treatment effects. Summary statistics (i.e., mean, slope, maximum response, range, proportion, achievable difference) will be used to effectively reduce the design to a 2 X 2 crossover and data will be analyzed accordingly (i.e., t-tests, linear regression, GEE, mixed model). Study findings will significantly contribute to the scientific basis of hot flash management in women following treatment for breast cancer.