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The Effects of Cannabis on Post Operative Recovery After Radical Cystectomy

21. juli 2026 oppdatert av: 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).

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Antatt)

20

Fase

  • Tidlig fase 1

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studer Kontakt Backup

Studiesteder

  • Forente stater
    • California
      • Palo Alto, California, Forente stater, 94304
        • Stanford University
        • Ta kontakt med:
        • Ta kontakt med:
        • Hovedetterforsker:
          • Jay Shah, MD

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: N/A
  • Intervensjonsmodell: Enkeltgruppeoppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Legemiddel: Cannabigerol
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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
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
Tiltaksbeskrivelse
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
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.
Baseline (prior to surgery), during treatment, and up to 1 month after treatment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Stanford University

Etterforskere

  • Hovedetterforsker: Jay Shah, MD, Stanford University

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. juli 2027

Primær fullføring (Antatt)

1. mai 2028

Studiet fullført (Antatt)

1. mai 2028

Datoer for studieregistrering

Først innsendt

4. mai 2026

Først innsendt som oppfylte QC-kriteriene

4. mai 2026

Først lagt ut (Faktiske)

11. mai 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

23. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • IRB-78197
  • NCI-2026-03511 (Registeridentifikator: National Cancer Institute: Clinical Trials Reporting Program)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Ja

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere