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下降。这种体重下降预示着早期死亡，与瘦肉组织侵蚀和明显的衰弱有关，并降低了生活质量。到目前为止，还没有一种治疗方法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。肌酸提供了一种新颖的方法。肌酸被运动员和“健美者”使用，已经在50多个临床试验中进行了研究，似乎可以增加体重，肌肉组织和力量，但短期毒性是可以接受的。据我们所知，还没有研究检测过癌症患者体内的肌酸。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，具体目的如下：

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