The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cannabigerol.
- Who it may be relevant to
- Registry conditions: Non-metastatic Bladder Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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).
Interventions
- 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.
Primary outcome measures
- 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)]
Secondary outcome measures (2)
- Change in Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30 [Time frame: 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 [Time frame: Baseline (prior to surgery), during treatment, and up to 1 month after treatment]
Eligibility criteria
Inclusion criteria
- 18 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.
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Stanford University — Palo Alto
Identifiers
NCT: NCT07577999 · IRB-78197 · NCI-2026-03511