A Prospective Cohort Study of Patients with Non-Small Cell Lung Cancer and Multiple Myeloma to Assess the Benefits and Harms Related to Cannabis Use During Treatment

对非小细胞肺癌和多发性骨髓瘤患者进行的前瞻性队列研究，以评估治疗期间使用大麻的益处和危害

• 批准号: 10792363
• 负责人: Jennifer Cullen
• 金额: $ 62.21万
• 依托单位: BECKMAN RESEARCH INSTITUTE/CITY OF HOPE
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-20 至 2028-08-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10792363
• 关键词: Address; Adjuvant; African American; American; Anxiety; Attention; Autologous Stem Cell Transplantation; Belief; Black race; Bortezomib; Cancer Patient; Cannabis; Clinics and Hospitals; Cohort Studies; Common Terminology Criteria for Adverse Events; Communication; Communities; Complex Variables; Computer software; Counseling; Data; Data Collection; Dexamethasone; Disease-Free Survival; Dose; Education; Ensure; Ethnic Origin; Gatekeeping; Goals; Health Personnel; Hematologic Neoplasms; Herb; Immune checkpoint inhibitor; Immunotherapy; Impaired cognition; Knowledge; Latino; Legal; Malignant Neoplasms; Malignant neoplasm of lung; Medical; Medical Marijuana; Multiple Myeloma; National Health and Nutrition Examination Survey; Neoadjuvant Therapy; Newly Diagnosed; Nivolumab; Non-Small-Cell Lung Carcinoma; Oncologist; Oncology; Operative Surgical Procedures; PD-1 inhibitors; Participant; Patients; Pattern; Perception; Pharmaceutical Preparations; Phytotherapy; Platinum; Population; Positioning Attribute; Prevalence; Prospective Studies; Prospective, cohort study; Psychoses; Quality of life; Race; Recommendation; Reporting; Sampling; Schedule; Socioeconomic Factors; Solid Neoplasm; Standardization; Surveys; Symptoms; Therapeutic; Treatment Protocols; Washington; abuse liability; active method; cancer therapy; cancer type; cannabis use behavior; chemotherapy; cohort; compliance behavior; demographics; inflammatory marker; instrument; lenalidomide; marijuana use; marijuana user; patient population; side effect

With the majority of Americans supporting legalization of medical cannabis, the number of patients asking their clinicians about medical cannabis has also significantly increased. Many clinicians, however, feel that they have inadequate knowledge about the efficacy, side effects, and abuse potential of medical cannabis. One national survey of oncologists reported that only 30% felt sufficiently informed to make recommendations regarding medical cannabis use, even though 80% regularly conducted conversations about medical cannabis with patients. A study from Washington State found 21% of patients with cancer surveyed had used cannabis in the past month. Despite the common belief among many patients that herbal therapies such as cannabis are inherently safe, the evidence is growing that greater caution is needed with cannabis as it may have potential direct side effects and may lead to interactions between herbs such as cannabis and medications. Thus, an important knowledge gap exists regarding the use of cannabis by patients with cancer during active cancer treatment, and this prospective cohort study is proposed to address these questions. This study aims to assess the prevalence and patterns of cannabis use among patients with cancers of the lung and multiple myeloma during active treatment as well as inquire about the communication patterns regarding cannabis use with their treating medical team. In order to reduce the complex variables that exist between the types of cancers and treatments, we will study two unique cancer populations – non-small cell lung cancer (NSCLC) and multiple myeloma (MM), with each cohort studied separately. These patients provide a homogenous population of patients with cancer that have generally standardized treatment regimens. Cancer patients currently receive platinum-based chemotherapy either before (neoadjuvant) or after (adjuvant) receiving surgery together with a PD-1 inhibitor (a type of immune checkpoint inhibitor (ICI), ex. nivolumab). Newly diagnosed MM patients are recommended to receive induction therapy with lenalidomide, bortezomib, and dexamethasone (RVd) for three to six months followed by an autologous stem cell transplant (ASCT). These two cohorts provide unique opportunities to study the impact of cannabis use in both a solid tumor and hematologic cancer during chemotherapy. For the NSCLC cohort, we will also assess the effect of cannabis on immunotherapy efficacy. For the MM cohort, we will assess the effects of cannabis during ASCT. Concurrently, we will survey oncology healthcare providers about their perceptions, education, and practice patterns regarding cannabis use by patients. Data collection will include information about all the medications including prescription, over-the- counter, herbs, and supplements in order to assess for the prevalence of potential medication interactions with cannabis. We hypothesize that a substantial proportion of patients receiving cancer treatment are using cannabis (~20%) and that there are different patterns of cannabis related benefits and harms based on cancer type and treatment as well as patient demographics including socioeconomic factors.

随着大多数美国人支持医用大麻合法化，询问他们的患者人数 关于医用大麻的临床医生也大大增加了。但是，许多临床医生感到他们 对医用大麻的有效性，副作用和滥用潜力的了解不足。一 国家对肿瘤学家的调查报告说，只有30％的人有适当的告知来提出建议 关于医用大麻的使用，即使80％的人经常进行有关医用大麻的对话 与患者。华盛顿州的一项研究发现，接受调查的癌症患者中有21％使用了大麻 在过去的一个月中。尽管许多患者普遍认为，大麻等草药疗法是 本质上是安全的，有证据表明大麻需要更加谨慎，因为它可能具有潜力 直接副作用，并可能导致大麻和药物等草药之间的相互作用。那，一个 关于活性癌症患者使用大麻的重要知识差距 治疗，并提出了这项前瞻性队列研究来解决这些问题。这项研究旨在评估 肺癌和多发性骨髓瘤患者中大麻使用的患病率和模式 在主动治疗期间以及询问有关大麻使用的沟通方式 治疗医疗团队。为了减少癌症类型之间存在的复杂变量 治疗方法，我们将研究两个独特的癌症种群 - 非小细胞肺癌（NSCLC）和多个 骨髓瘤（mm），每个队列分别研究。这些患者提供的同质人群 患有普遍标准化治疗方案的癌症患者。癌症患者目前接受 基于铂的化学疗法要么（新辅助）或（辅助）接受手术以及 PD-1抑制剂（一种免疫切除点抑制剂（ICI），例如Nivolumab）。新诊断的MM患者是 建议接受Lenalidomide，Bortezomib和地塞米松（RVD）接受诱导疗法三个 到六个月，然后进行自体干细胞移植（ASCT）。这两个队列提供了独特的 在研究过程中研究大麻使用对实体瘤和血液学癌症的影响的机会 化学疗法。对于NSCLC队列，我们​​还将评估大麻对免疫疗法有效性的影响。 对于MM队列，我们​​将评估ASCT期间大麻的影响。同时，我们将调查肿瘤学 医疗保健提供者关于他们有关大麻使用的看法，教育和实践模式 患者。数据收集将包括有关所有药物的信息，包括处方，过度 计数器，草药和补充剂，以评估与潜在药物相互作用的普遍性 大麻。我们假设接受癌症治疗的患者很大一部分正在使用 大麻（约20％），并且基于癌症有不同的大麻相关益处和危害 类型和治疗以及患者人口统计信息，包括社会经济因素。