The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy

NCT07577999 | Not Yet Recruiting Early Phase 1 FDA Drug

• 2 other identifiers: IRB-78197NCI-2026-03511
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Non-metastatic Bladder Cancer

Keywords

Cannabigerol; Hemp-Derived Cannabinoid; Health-Related Quality of Life; Supportive Care

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30

  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

  Baseline (prior to surgery), during treatment, and up to 1 month after treatment

Study Arms (1)

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.

Drug: Cannabigerol

Interventions

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.

Cannabigerol Gummies

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Non-metastatic bladder cancer scheduled to undergo radical cystectomy and urinary diversion
• Patient is able to understand consent and is willing and able to provide written informed consent
• Patient makes their own medical decisions
• Lives in state of California
• Patient is able and willing to refrain from using any non-study cannabis during the screening and treatment phases of the study
• Females of childbearing potential to utilize an acceptable birth control method while consuming the gelatin-based chewable medication
• Be able to read and understand the study questionnaires
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University

Palo Alto, California, 94304, United States

Location

MeSH Terms

Interventions

cannabigerol

Study Officials

• Jay Shah, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophia Prendiville

CONTACT

239-691-8994; sprend19@stanford.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 11, 2026
• Study Start (Estimated): July 1, 2027
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028
• Last Updated: May 11, 2026

Record last verified: 2026-05

Locations

US (1)