Arjun Gupta, Kendall Lin, Ella Chrenka, Grace Gilmore, Jordan Cowger, David Rak, Dylan Zylla
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引用次数: 0
Abstract
Background: In a pilot waitlist-control randomized trial, a personalized medical cannabis intervention improved certain symptoms among patients with pancreatic cancer over 8 weeks. Longer-term and dose-response data can guide future trial design.
Methods: CANPAN enrolled 32 cannabis-naïve patients with newly diagnosed locally advanced/metastatic pancreatic adenocarcinoma (NCT06605430). Patients were randomized to early (0-8 weeks) or delayed (9-16 weeks) cannabis intervention. Primary efficacy results over the first 8 weeks were previously reported. We investigated cannabis use and patient-reported outcome (PRO) completion over 9-16 weeks, and the relationship between tetrahydrocannabinol (THC) dose and symptom efficacy.
Results: Among 32 participants, 23 (72%) used cannabis during their assigned 8-week period (12/16 in early arm and 11/16 in delayed arm). Of these, 16 (50%) had both pre-cannabis and 8-week post-cannabis initiation PRO data available. At the end of the 16-week study period, PRO data were available for 16 (50%) participants (9/16 early arm, 7/16 delayed arm). Median daily THC dose 4 weeks after starting cannabis was similar in early vs delayed arms (10 mg vs 9.3 mg). A higher average daily THC dose was associated with improvements in anxiety (r = 0.52, P = .038) and insomnia (r = 0.53, P = .033). A ≥ 10 mg daily THC dose (vs <10 mg) was associated with mean improvement in 4 vs 2.1 symptoms.
Conclusions: The 50% complete data availability at 16 weeks, dose-response relationship with psychological symptoms, and threshold dose for multi-symptom efficacy will guide future trials. Similar cannabis use patterns across arms raise confidence in the waitlist-control design.
背景:在一项试点候补对照随机试验中,个体化医用大麻干预在8周内改善了胰腺癌患者的某些症状。长期和剂量反应数据可以指导未来的试验设计。方法:CANPAN纳入32例新诊断的局部晚期/转移性胰腺腺癌(NCT06605430) cannabis-naïve患者。患者被随机分为早期(0-8周)或延迟(9-16周)大麻干预组。前8周的主要疗效结果已被报道。我们调查了9-16周的大麻使用和患者报告的预后(PRO)完成情况,以及四氢大麻酚(THC)剂量与症状疗效之间的关系。结果:在32名参与者中,23名(72%)在指定的8周期间使用大麻(早期组12/16,延迟组11/16)。其中,16例(50%)同时具有大麻前和大麻后8周的PRO数据。在16周的研究期结束时,16名(50%)参与者(9/16早期组,7/16延迟组)的PRO数据可用。在开始吸食大麻4周后,早期组和延迟组的每日四氢大麻酚剂量中位数相似(10毫克对9.3毫克)。较高的平均每日四氢大麻酚剂量与焦虑(r 0.52, p = 0.038)和失眠(r 0.53, p = 0.033)的改善相关。结论:16周时50%的完整数据、与心理症状的剂量-反应关系以及多症状疗效的阈值剂量将指导未来的试验。类似的大麻使用模式增加了对候补名单控制设计的信心。
期刊介绍:
The Oncologist® is dedicated to translating the latest research developments into the best multidimensional care for cancer patients. Thus, The Oncologist is committed to helping physicians excel in this ever-expanding environment through the publication of timely reviews, original studies, and commentaries on important developments. We believe that the practice of oncology requires both an understanding of a range of disciplines encompassing basic science related to cancer, translational research, and clinical practice, but also the socioeconomic and psychosocial factors that determine access to care and quality of life and function following cancer treatment.