Acupuncture for hot flashes in cancer pts: pilot for RCT

描述(申请人提供)：背景：潮热是乳腺癌和前列腺癌治疗的常见副作用。一半到三分之二的乳腺癌和前列腺癌患者报告潮热，其中许多人认为他们的问题中等或非常严重。有几种药物可用，但临床相关的不良反应很常见，应答率中等。内源性阿片类药物与潮热有关。已知针刺导致内啡肽释放，也有初步证据表明，针刺可能导致内源性阿片类药物基因表达的变化。几项单臂研究表明，针灸治疗后潮热的大幅和持续减少。一项针对更年期潮热的随机试验也取得了令人鼓舞的结果。这些考虑需要进一步研究针灸治疗与癌症治疗相关的潮热。 目的：1.确定针灸治疗乳腺癌和/或前列腺癌潮热的第三阶段试验是否合理：2.确定第三阶段试验是否可行；3.确定乳腺癌和前列腺癌患者是否应该合并在一项第三阶段试验中；4.确定是否需要评估潮热的严重程度；5.为样本量计算提供必要的数据 方法：对有治疗相关性潮热的癌症患者进行为期一周的潮热日记。然后，他们将被随机分成八次真针灸或安慰剂针灸治疗，为期四周。安慰剂针灸是由一根可以缩进手柄内的针组成的，这种方法已经被证明对患者是可信的。潮热日记将在随机抽样后的6周、13周和26周完成。通过协方差分析比较潮热频率和潮热评分(频率乘以严重程度)的变化。乳腺癌和前列腺癌患者将分别进行统计和分析。将结合数据进行探索性分析：将进行交互测试，以确定针灸是否对不同癌症类型的潮热有不同的影响。在试验结束时，我们将有如下数据来解决我们的每个目标：目标1：两组均值之间差异的可信区间；目标2：累积率、辍学率、治疗依从性、非研究外治疗的使用；目标3：诊断和治疗效果、相对累积率和辍学率、相对依从性之间的交互作用；目标4：潮热评分和潮热发作频率之间的相关性；目标5：标准差、对照组的均值、基线和后续措施之间的相关性。

DESCRIPTION (provided by applicant): BACKGROUND: Hot flashes are a common side-effect of treatment for breast and prostate cancer. Between one-half and two-thirds of breast and prostate cancer patients report hot flashes, and many of these rate their problem as moderately or extremely severe. Several drugs are available, but clinically relevant adverse effects are common and response rates are moderate. Endogenous opioids have been implicated in hot flashes. It is known that acupuncture leads to endorphin release and there is also preliminary evidence that acupuncture may lead to changes in the genetic expression of endogenous opioids. Several single-arm studies have shown large and persistent decreases in hot flashes following acupuncture treatment. A randomized trial in menopausal hot flashes also had encouraging results. These considerations warrant further research on acupuncture for hot flashes associated with cancer treatment. OBJECTIVES: 1. To determine whether a Phase III trial of acupuncture for hot flashes in breast and/or prostate cancer is warranted: 2. To determine whether a Phase III trial is feasible; 3. To determine whether breast and prostate cancer patients should be combined in a single Phase III trial; 4. To determine whether severity of hot flashes need be assessed; 5. To provide data necessary for sample size calculation METHODS: Cancer patients with treatment related hot flashes will complete a diary of hot flashes for one week. They will then be randomized to eight sessions of true or placebo acupuncture over four weeks. Placebo acupuncture consists of a needle that retracts inside its handle, a method that has been shown to be credible to patients. Hot flash diaries will be completed at six, 13 and 26 weeks following randomization. Change in hot flash frequency and hot flash score (frequency multiplied by severity) will be compared by analysis of co-variance. Breast and prostate patients will be accrued and analyzed separately. Data will be combined for exploratory analyses: a test for interaction will be made to determine whether acupuncture has differential effects on hot flashes by type of cancer. At the end of the trial we will have data to address each of our objectives as follows: Objective 1: Confidence interval for the difference between group means; Objective 2: Accrual rate, drop-out rate, compliance with treatment, use of off-study treatments; Objective 3: Interaction between diagnosis and treatment effect, relative accrual and drop-out rate, relative compliance; Objective 4: Correlation between hot flash score and hot flash frequency; Objective 5: Standard deviations, mean of control group, correlation between and within baseline and follow-up measures.