IPElife: Phase III, double-blind trial of <i>cannabis sativa</i> extract in pain management and quality of life in patients with metastatic lung cancer.

12061 Background: Pain and deterioration in quality of life (QoL) are among the most common and problematic symptoms reported by patients with late-stage lung cancer. Thus, cannabis sativa extract has been identified as a potencial adjuctive therapy for enhancing QoL and managing symptoms, including oncology pain. Objective: The aim is to assess pain management and quality of life in patients with locally advanced or metastatic lung cancer using cannabis sativa extract. Methods: A randomized, prospective, double-blind, placebo-controlled, phase III trial was conducted, which included patients, which included patients with locally advanced or metastatic lung confirmed by histopathology. The participants were subdivided into two groups of 20 patients each, with 1:1 allocation ratio. The primary outcome was pain control, measured using the Visual Analog Scale (VAS) for pain. The secondary outcomes included quality of life, assessed using the EORTC QLQ-C30 and its specific module for lung cancer (QLQ-LC13). The cannabis sativa extract administration protocol involved dose escalation, starting at 10mg/day, with titration every 5 days until the patients reached their goals or the maximum dose of 100mg/day. The questionnaires and the VAS scale were applied every 21 days from T1 to T5. Continuous variables were analyzed using the paired t-test or signed-rank test, depending on the date distribution. Results: The difference in mean pain scores (measured using the EVA tool) was greater in the CBD group compared to the placebo group between periods T1 and T5 (5.0 vs 3.7) (Table1). Similarly, the difference in mean pain scores, as measured using the EORTC-QLQ-C30 scale (47.2 vs 35.7), favored the CBD group. Regarding the quality of life analysis, in the overall assessment date were not statistically significant, however difference was observed in the levels of insomnia (p-value 0.01) and dyspnea (p-value 0.02) between patients in the CBD and placebo groups, with results favoring the CBD group. Conclusion: The cannabis sativa extract may be considered an adjuvant in the management of pain and quality of life in patients with metastatic lung cancer and locally advanced. Clinical trial information: 6.036.463 . Pain control analysis by the EVA scale between times. T1 T3 T5 Mean (SD) Mean (SD) Mean (SD) CBD group 7.2 (2.1) 3.3 (2.6) 2.2 (2.4) Placebo group 7.4 (1.8) 3.7 (3.1) 3.7 (3.3) Average EVA scale scores by group and time.