This will be an open-label, single group supportive care pilot study in which patients are given cannabinoid gummies in the perioperative setting to alleviate RC/UD symptoms and improve quality of life. The primary objective will be to evaluate the safety and tolerability of a cannabigerol supplement used perioperatively (from 14 days prior to surgery to 30 days following surgery) by patients undergoing radical cystectomy with urinary diversion (RC/UD).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
20
Gelatin-based chewable gummies containing 25 mg of cannabigerol derived from hemp, administered for one month following a two-week lead-in dose-adjustment period.
Stanford University
Palo Alto, California, United States
Incidence of Grade ≥2 Adverse Events and Dose-Limiting Toxicities
Assessment of safety and tolerability of hemp-derived cannabigerol gummies based on the incidence of Grade ≥2 adverse events (AEs) that are unresponsive to dose reduction or medical management. AEs of interest include tachycardia, xerostomia, dizziness, nausea, anxiety/depression, euphoria/impairment, fatigue, and memory impairment. Tolerability will also be evaluated by the frequency of: Dose reductions Treatment discontinuations Patient-reported tolerability (including taste, texture, and overall acceptability) All AEs will be graded using standard toxicity criteria and recorded throughout the study. Dose adjustments and discontinuations will be documented and attributed to treatment.
Time frame: From treatment initiation through 1 month post-treatment (including 2-week lead-in period)
Change in Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Change in HRQoL as measured by the Change in Health-Related Quality of Life - European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) total and domain scores from baseline (pre-intervention) to during and after treatment with cannabigerol following cystectomy with urinary diversion. Higher scores indicate better functioning for functional scales and worse symptoms for symptom scales, per instrument scoring guidelines.
Time frame: Baseline (pre-surgery), during treatment, and up to 1 month post-treatment
Change in Health-Related Quality of Life - Functional Assessment of Cancer Therapy-Bladder Cystectomy
Change in HRQoL as measured by the FACT-Bl-Cys questionnaire from baseline to during and after treatment. Scores will be calculated according to instrument guidelines.
Time frame: Baseline (prior to surgery), during treatment, and up to 1 month after treatment
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