Clinical trial · Interventional
The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy
NCT07577999CI-TRIAL-00119164not yet recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-metastatic Bladder Cancer | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cannabigerol | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cannabigerol Gummies
- 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.
- interventionNames
- Drug: Cannabigerol
Primary outcomes (1)
- measure
- Incidence of Grade ≥2 Adverse Events and Dose-Limiting Toxicities
- timeFrame
- From treatment initiation through 1 month post-treatment (including 2-week lead-in period)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.