Creatine: Is It a Body Builder for Cancer Patients?

描述(申请人提供)：超过60%的晚期癌症患者体重减轻。这种体重减轻预示着过早死亡，与瘦组织侵蚀和明显虚弱有关，并降低生活质量。到目前为止，还没有任何治疗方法被证明可以逆转难治性晚期癌症患者的体重减轻及其毁灭性后果。肌酸提供了一种新的方法。肌酸被运动员和“健美运动员”使用，已经在50多项临床试验中进行了研究，似乎可以增加体重、肌肉和力量，并具有可接受的短期毒性。据我们所知，还没有研究检测癌症患者的肌酸。基于十年来对癌症患者减肥问题的临床研究，我们假设肌酸也可能对癌症患者有益。因此，我们建议进行肌酸试验，具体目标如下： 1.探讨肌酸是否能稳定减肥癌症患者的体重。我们将比较25名接受肌酸治疗的患者和25名接受安慰剂治疗的患者在6周内持续体重减轻(大于或等于基线体重的5%)的百分比，这些患者都接受相同的化疗方案。我们还将比较两个治疗组之间的体重减轻时间。 2.探讨肌酸是否能增加减肥癌症患者的瘦身组织和提高力量。在同一组50名患者中，我们将在基线和6周时测量瘦组织和握力。我们将对治疗臂之间的这两个参数进行直接比较。 3.探讨肌酸的毒性和生活质量是否可接受。我们将获得这50名患者的纵向毒性和生活质量数据，并将在毒性发生率和严重程度以及最高生活质量评分方面对治疗组进行直接比较。

DESCRIPTION (provided by applicant): Over 60% of advanced cancer patients suffer weight loss. This weight loss predicts early death, is associated with lean tissue erosion and marked debility, and detracts from quality of life. To date, no treatment has been shown to reverse weight loss and its devastating consequences in patients with refractory, advanced cancer. Creatine offers a novel approach. Used by athletes and "body builders," creatine has been studied in over 50 clinical trials and appears to augment weight, musculature, and strength with an acceptable short-term toxicity profile. To our knowledge, no study has examined creatine in cancer patients. Building upon a decade's worth of clinical investigation into weight loss issues in cancer patients, we hypothesize that creatine may benefit cancer patients as well. We therefore propose a trial with creatine with the following specific aims: 1. To explore if creatine stabilizes weight in weight-losing cancer patients. We will compare the percentage of patients with continued weight loss (greater than or equal too 5% of baseline weight) over 6 weeks in a cohort of 25 creatine-treated and 25 placebo-treated patients, all of whom are receiving the same chemotherapy regimen. We will also compare time-to-weight loss between the two treatment arms. 2. To explore whether creatine augments lean tissue and improves strength in weight-losing cancer patients. We will measure lean tissue and handgrip strength at baseline and at 6 weeks in this same cohort of 50 patients. We will make direct comparisons of these 2 parameters between treatment arms. 3. To explore whether creatine's toxicity and quality of life profile is acceptable. We will obtain longitudinal toxicity and quality of life data on this same cohort of 50 patients and will make direct comparisons between treatment arms on toxicity incidence and severity and on maximal quality of life scores