Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07577999

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).

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Non-metastatic Bladder Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. 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)

    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.

Secondary outcomes

  1. 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 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.

  2. 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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Jay Shah, MD

CONTACT

[email protected]

(650) 497-9937

Ned Realiza

CONTACT

[email protected]

650-498-8496

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Registry information

Important dates

Study start
2027
Primary completion
2028
Study completion
2028
First posted
May 11, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.