Non-metastatic Bladder Cancer
Conditions
Keywords
Cannabigerol, Hemp-Derived Cannabinoid, Health-Related Quality of Life, Supportive Care
Brief 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. 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
DRUGCannabigerol
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.
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Grade ≥2 Adverse Events and Dose-Limiting Toxicities | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30 | 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. |
| Change in Health-Related Quality of Life - Functional Assessment of Cancer Therapy-Bladder Cystectomy | 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. |
Countries
United States
Contacts
CONTACTJay Shah, MD
CONTACTNed Realiza
PRINCIPAL_INVESTIGATORJay Shah, MD
Stanford University
Outcome results
None listed