The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy
21. juli 2026 opdateret af: Stanford University
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).
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
20
Fase
- Tidlig fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ned Realiza
- Telefonnummer: 650-498-8496
- E-mail: nrealiza@stanford.edu
Undersøgelse Kontakt Backup
- Navn: Jay Shah, MD
- Telefonnummer: (650) 497-9937
- E-mail: jbshah@stanford.edu
Studiesteder
-
-
California
-
Palo Alto, California, Forenede Stater, 94304
- Stanford University
-
Kontakt:
- Ned Realiza
- Telefonnummer: 650-498-8496
- E-mail: nrealiza@stanford.edu
-
Kontakt:
- Jay Shah
- Telefonnummer: (650) 497-9937
- E-mail: jbshah@stanford.edu
-
Ledende efterforsker:
- Jay Shah, MD
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Cannabigerol Gummies
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.
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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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Incidence of Grade ≥2 Adverse Events and Dose-Limiting Toxicities
Tidsramme: 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. |
From treatment initiation through 1 month post-treatment (including 2-week lead-in period)
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Health-Related Quality of Life (HRQoL) - EORTC QLQ-C30
Tidsramme: 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.
|
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
Tidsramme: Baseline (prior to surgery), during treatment, and up to 1 month after treatment
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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.
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Baseline (prior to surgery), during treatment, and up to 1 month after treatment
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Jay Shah, MD, Stanford University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
1. juli 2027
Primær færdiggørelse (Anslået)
1. maj 2028
Studieafslutning (Anslået)
1. maj 2028
Datoer for studieregistrering
Først indsendt
4. maj 2026
Først indsendt, der opfyldte QC-kriterier
4. maj 2026
Først opslået (Faktiske)
11. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
23. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- IRB-78197
- NCI-2026-03511 (Registry Identifier: National Cancer Institute: Clinical Trials Reporting Program)
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .