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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2026-03511 | Registry Identifier | National Cancer Institute: Clinical Trials Reporting Program |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cannabigerol Gummies | Experimental | Participants will receive cannabigerol gummies (oral, gelatin-based chewable formulation), 25 milligrams per gummy. Dosing will begin approximately 2 weeks prior to cystectomy with urinary diversion at 12.5 milligrams (one-half gummy) three times daily after meals. Based on tolerability, the dose may be increased to 25 milligrams (one gummy) three times daily or reduced to 6.25 milligrams (one-quarter gummy) 1 to 3 times daily. Treatment will continue through the perioperative period and up to 30 days postoperatively. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cannabigerol | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From treatment initiation through 1 month post-treatment (including 2-week lead-in period) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophia Prendiville | Contact | 239-691-8994 | sprend19@stanford.edu |
| Name | Affiliation | Role |
|---|---|---|
| Jay Shah, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Palo Alto | California | 94304 | United States |
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| ID | Term |
|---|---|
| C037036 | cannabigerol |
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| 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. | Baseline (prior to surgery), during treatment, and up to 1 month after treatment |