The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy

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 Overview

• Status: Not yet recruiting
• Conditions: Non-metastatic Bladder Cancer
• Intervention / Treatment: Drug: Cannabigerol

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Sophia Prendiville; Phone Number: 239-691-8994; Email: sprend19@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 18 years of age or older
2. Non-metastatic bladder cancer scheduled to undergo radical cystectomy and urinary diversion
3. Patient is able to understand consent and is willing and able to provide written informed consent
4. Patient makes their own medical decisions
5. Lives in state of California
6. Patient is able and willing to refrain from using any non-study cannabis during the screening and treatment phases of the study
7. Females of childbearing potential to utilize an acceptable birth control method while consuming the gelatin-based chewable medication
8. Be able to read and understand the study questionnaires
9. Patient agrees to not to operate heavy machinery or engage in activities that require mental alertness while taking the gelatin-based chewable cannabigerol medication, as these substances may cause drowsiness.

Exclusion Criteria:

1. History of substance abuse
2. History of psychosis or schizophrenia
3. CBD or Cannabigerol usage in the last 30 days
4. THC usage in the last 30 days
5. Pregnant or breastfeeding individuals
6. Patients who have had heart attack or acute coronary syndrome in the 90 days prior to surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Cannabigerol Gummies; 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.

Drug: Cannabigerol; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Jay Shah, MD, Stanford University

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: May 4, 2026
• First Submitted That Met QC Criteria: May 4, 2026
• First Posted (Actual): May 11, 2026

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Supportive Care; Health-Related Quality of Life; Cannabigerol; Hemp-Derived Cannabinoid
• Additional Relevant MeSH Terms: cannabigerol
• Other Study ID Numbers: IRB-78197; NCI-2026-03511 (Registry Identifier: National Cancer Institute: Clinical Trials Reporting Program)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No