The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy

Part of paid clinical trials in Palo Alto, California.

Sponsor
Stanford University
Study ID
NCT07577999
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • Non-metastatic Bladder Cancer

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

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.

Study Details

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).

Key Dates

Start date
Jul 31, 2027
Status verified
May 2026
Primary completion
May 31, 2028
Completion
May 31, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

  • 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.

Primary Outcome Measure

Incidence of Grade ≥2 Adverse Events and Dose-Limiting Toxicities [ Time Frame: From treatment initiation through 1 month post-treatment (including 2-week lead-in period) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Stanford UniversityPalo AltoCalifornia94304-

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Stanford University· Palo Alto, CA