A Pilot Study to Evaluate the Benefits of Phytocannabinoids for the Treatment of Chronic Chemotherapy-Induced Peripheral Neuropathy

项目摘要 超过1500万癌症幸存者生活在美国，但不幸的是，这些患者中有很大一部分经历了 治疗带来的长期副作用。这包括神经病，它的典型特征是 四肢的异常症状，包括刺痛、麻木、疼痛或灼热。当病情严重和慢性时， 神经病可能会干扰患者生活的方方面面，降低他们的生活质量。不幸的是，这些人 对于患者来说，没有一种治疗方法能成功帮助患者完全消除症状。有30多个州 合法提供医用大麻，在癌症患者中越来越受欢迎。然而， 癌症社区几乎没有数据来指导患者使用它。通过评估大麻的效果 在神经病方面，我们将能够解决这一重要的知识差距。 医用大麻中发现的两种重要化合物是大麻二酚(CBD)和四氢大麻酚(THC)。 这项临床试验将随机将乳腺癌和结肠癌幸存者与慢性化疗诱导的外周血 两种医用大麻的神经病-CBD与CBD+THC。患者将被随机分配到CBD， CBD+THC，或安慰剂，治疗8周。这项研究的结果与癌症高度相关。 因为这一发现可能适用于其他癌症相关的疼痛综合征。 这项初步研究产生的数据将提供适当设计所需的重要初步信息 一项评估大麻治疗CIPN疗效的更大规模的随机临床试验。通过帮助 患者减少CIPN症状，我们将帮助他们提高生活质量，提高他们重返工作岗位的能力，以及 他们保持积极生活方式的能力，越来越多地被证明有助于减少复发 癌症的威胁。

Project Summary Over 15 million cancer survivors live in the US, but unfortunately a large proportion of these patients experience long-term side effects from their treatments. This includes neuropathy, which is typically characterized by abnormal symptoms in the extremities including tingling, numbness, pain, or burning. When severe and chronic, neuropathy can interfere with all aspects of a patient’s life, diminishing their quality of life. Unfortunately for these patients, no therapy has been successful in helping patients entirely eliminate symptoms. With over 30 states legally providing medical cannabis, it has become increasing popular among cancer patients. However, the cancer community has very little data in which to guide patients about its use. By evaluating cannabis’s effect on neuropathy, we will be able to address this important gap in knowledge. Two important compounds found in medical cannabis are cannabidiol (CBD) and tetrahydrocannabinol (THC). This clinical trial will randomize breast and colon cancer survivors with chronic chemotherapy-induced peripheral neuropathy to two kinds of medical cannabis – CBD versus CBD+THC. Patients will be randomized to CBD, CBD+THC, or placebo and will be treated for 8 weeks. The results of this research are highly relevant to cancer survivors as a whole because the findings could be potentially applied to other cancer related pain syndromes. The data generated from this pilot study will provide important preliminary information needed to properly design a larger randomized clinical trial to evaluate the efficacy of cannabis for the treatment of CIPN. By helping patients reduce the symptoms of CIPN, we will help improve their quality of life, their ability to return to work, and their capacity to maintain an active lifestyle, which has increasingly been shown to help reduce the recurrence of cancer.