Non-metastatic Bladder CancerEarly Phase 1NCT07577999
The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy
A Early Phase 1 study testing Cannabigerol in people with Non-metastatic Bladder Cancer, run by Stanford University at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-metastatic Bladder Cancer
- What is being tested?
- Cannabigerol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2027to May 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Stanford University
Palo Alto, California, 94304
Jay Shah, (650) 497-9937, jbshah@stanford.edu
Ned Realiza, 650-498-8496, nrealiza@stanford.edu
About this study
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
- Non-metastatic Bladder Cancer
- Being tested
- Cannabigerol
- Keywords
- Cannabigerol, Hemp-Derived Cannabinoid, Health-Related Quality of Life, Supportive Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CannabigerolDrug
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 group | Role | What they receive |
|---|---|---|
| Cannabigerol Gummies | Experimental | 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. Receives: Drug: Cannabigerol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Grade ≥2 Adverse Events and Dose-Limiting Toxicities
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.
Measured: From treatment initiation through 1 month post-treatment (including 2-week lead-in period)
Secondary outcomes (2)
Change in Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
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.
Measured: 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
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.
Measured: Baseline (prior to surgery), during treatment, and up to 1 month after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study startJul 2027 (estimated)
- Primary completionMay 2028 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-metastatic Bladder CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jay Shah, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07577999
- Sponsor's protocol ID
- IRB-78197
- Other IDs
- NCI-2026-03511
- Status last verified
- Jul 2026
- First submitted
- 4 May 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy
- ClinicalTrials.gov ID
- NCT07577999
- Acronym / sponsor ID
- IRB-78197
- Conditions
- Non-metastatic Bladder Cancer
- Keywords
- Cannabigerol, Hemp-Derived Cannabinoid, Health-Related Quality of Life, Supportive Care
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jul 2027 (estimated)
- Primary completion
- May 2028 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 11 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cannabigerol Gummies | Experimental | Drug: CannabigerolParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CannabigerolGelatin-based chewable gummies containing 25 mg of cannabigerol derived from hemp, administered for one month following a two-week lead-in dose-adjustment period. | Drug | Cannabigerol Gummies |
Primary outcome
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jay Shah, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Cannabigerol in people with Non-metastatic Bladder Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jay Shah, MD ((650) 497-9937, jbshah@stanford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2026.