The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy

Stanford University

Status and phase: Begins enrollment in 9 months; Early Phase 1

Conditions: Non-metastatic Bladder Cancer

Treatments: Drug: Cannabigerol

Study type: Interventional

Funder types: Other

Identifiers

NCT07577999

NCI-2026-03511 (Registry Identifier)

IRB-78197

Details and patient eligibility

About

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).

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Cannabigerol Gummies

Experimental group

Description:

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.

Treatment:

Drug: Cannabigerol