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Evaluation of Naloxegol in the Prevention of POI After Cystectomy (ANTAGOCYST)

Primary Purpose

Bladder Cancer, Cystostomy; Complications

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Naloxégol oxalate
Placebo oral tablet
Sponsored by
Institut Paoli-Calmettes
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring Radical cystectomy, Postoperative ileus, Enhanced Recovery After Surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients aged ≥ 18 years
  • Informed consent signed
  • Histopathological confirmation of bladder cancer
  • Patients undergoing radical cystectomy and urinary diversion for an oncological indication
  • Patients able to understand the study procedures, agreed to participate in the study program
  • Patients affiliated to the national "Social Security" regimen or beneficiary of this regimen

Exclusion Criteria:

  • Unwilling to undergo cystectomy
  • Cystectomy for non-oncological indication
  • Patients with concomitant upper urinary tract disease
  • Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy
  • Previous pelvic radiotherapy for prostate or bladder cancer
  • Patients having taken opioids for more than seven days before surgery (to prevent peripheral withdrawal effects)
  • Patients treated with drugs metabolized by certain enzymes (CYP3A4 and P-gp)
  • Patients with severe hepatic impairment
  • Patients with end-stage renal disease
  • Patients with heart failure
  • Patients with severe dementia that impacts daily functioning
  • Pregnant and lactating females
  • Not postmenopausal females and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm)
  • Patients participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or medical device study or any study in which active patient participation was required outside normal hospital data collection during the course of this study
  • Patients deprived of liberty or placed under the authority of a tutor or curator

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    Experimental Treatment

    Placebo

    Arm Description

    ERAS program with administration of experimental treatment: Naloxegol 25mg administrated once daily from surgery for up to 7 days

    ERAS program with administration of placebo: Placebo administrated once daily from surgery for up to 7 days

    Outcomes

    Primary Outcome Measures

    Time of hospital discharge
    Comparaison between treatment group and placebo group for post-operative length of stay between the date of hospital discharge and the date of surgery

    Secondary Outcome Measures

    Rate of reinsertion of nasogastric tube
    Comparaison between treatment group and placebo group for rate of reinsertion of nasogastric tube
    Time to reach gastrointestinal recovery
    Comparaison between treatment group and placebo group for time ot reach gastrointestinal recovery
    Rate of 30-day postoperative complications
    Comparaison between treatment group and placebo group for rate of 30-day postoperative complications with Clavien-Dindo classification grade I-V
    Rate of major postoperative complications of 90-day postoperative period
    Comparaison between treatment group and placebo group for rate of major postoperative complications with Clavien-Dindo classification grade III-IV-V

    Full Information

    First Posted
    December 20, 2019
    Last Updated
    July 27, 2020
    Sponsor
    Institut Paoli-Calmettes
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04219046
    Brief Title
    Evaluation of Naloxegol in the Prevention of POI After Cystectomy
    Acronym
    ANTAGOCYST
    Official Title
    Evaluation of Naloxegol, a Peripherally Acting µ-opioid Receptor Antagonist, in the Prevention of Postoperative Ileus After Cystectomy
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2021 (Anticipated)
    Primary Completion Date
    September 2022 (Anticipated)
    Study Completion Date
    December 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Institut Paoli-Calmettes

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    Postoperative ileus (POI) is defined as a transient reduction of bowel motility that prevents effective transit of bowel content and tolerance of oral intake following surgical interventions, especially after radical cystectomy. It remains a major factor associated with postoperative morbidity, length of hospital stay and medical costs. In order to optimize perioperative care for patients undergoing radical cystectomy in a context of an ERAS (Enhanced Recovery After Surgery) program, we will evaluate the effectiveness of systemic pharmacologic opioid antagonist treatment.
    Detailed Description
    Radical cystectomy (RC) with urinary diversion represents the gold standard treatment for muscle-invasive bladder cancer. Postoperative ileus (POI) is defined as a transient reduction of bowel motility that prevents effective transit of bowel content and tolerance of oral intake following surgical interventions, especially after RC. It remains a major factor associated with postoperative morbidity, length of hospital stay and medical costs. Faster gastrointestinal recovery and prevention of POI are at the heart of ERAS (Enhanced Recovery After Surgery) protocols. In order to optimize the post-operative consequences of patients operated on for a cystectomy within the framework of a RAAC program, several provisions aim to alleviate post-operative gastrointestinal dysfunctions. Naloxegol, peripherally acting µ-opioid receptor antagonist, is currently approved for opioid-induced constipation in Chronic Non-Cancer Pain, but its potential interest to prevent POI has never been assessed. In this randomized, double-blind, placebo-controlled trial, the administration of Naloxegol for a limited duration as part of ERAS (Enhanced Recovery After Surgery) program will be evaluated to reduce the time of hospital discharge (length of stay) and to reduce the rate of postoperative complications. Priamry and secondary objectives will be compared between naloxegol and placebo groups.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bladder Cancer, Cystostomy; Complications
    Keywords
    Radical cystectomy, Postoperative ileus, Enhanced Recovery After Surgery

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Model Description
    Randomized, Double-blind, placebo-controlled
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    102 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental Treatment
    Arm Type
    Experimental
    Arm Description
    ERAS program with administration of experimental treatment: Naloxegol 25mg administrated once daily from surgery for up to 7 days
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    ERAS program with administration of placebo: Placebo administrated once daily from surgery for up to 7 days
    Intervention Type
    Drug
    Intervention Name(s)
    Naloxégol oxalate
    Other Intervention Name(s)
    Naloxegol
    Intervention Description
    Oral administration once daily
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo oral tablet
    Other Intervention Name(s)
    Placebo
    Intervention Description
    Oral administration once daily
    Primary Outcome Measure Information:
    Title
    Time of hospital discharge
    Description
    Comparaison between treatment group and placebo group for post-operative length of stay between the date of hospital discharge and the date of surgery
    Time Frame
    Date at which treatment is initiated and date of hospital discharge (up to 12 days)
    Secondary Outcome Measure Information:
    Title
    Rate of reinsertion of nasogastric tube
    Description
    Comparaison between treatment group and placebo group for rate of reinsertion of nasogastric tube
    Time Frame
    From post-surgery to hospital discharge (up to 12 days)
    Title
    Time to reach gastrointestinal recovery
    Description
    Comparaison between treatment group and placebo group for time ot reach gastrointestinal recovery
    Time Frame
    Date at which the patient has the first gaz from post-surgery (up to 12 days)
    Title
    Rate of 30-day postoperative complications
    Description
    Comparaison between treatment group and placebo group for rate of 30-day postoperative complications with Clavien-Dindo classification grade I-V
    Time Frame
    Postoperative complications from surgery, to 30-day postsurgery and to 90 postsurgery with Clavien-Dindo classification (up to 3 motnhs)
    Title
    Rate of major postoperative complications of 90-day postoperative period
    Description
    Comparaison between treatment group and placebo group for rate of major postoperative complications with Clavien-Dindo classification grade III-IV-V
    Time Frame
    Major postoperative complications from surgery to 90 postsurgery with Clavien-Dindo classification (up to 3 motnhs)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients aged ≥ 18 years Informed consent signed Histopathological confirmation of bladder cancer Patients undergoing radical cystectomy and urinary diversion for an oncological indication Patients able to understand the study procedures, agreed to participate in the study program Patients affiliated to the national "Social Security" regimen or beneficiary of this regimen Exclusion Criteria: Unwilling to undergo cystectomy Cystectomy for non-oncological indication Patients with concomitant upper urinary tract disease Previous total colectomy, gastrectomy, or gastric bypass, or functional colostomy or ileostomy Previous pelvic radiotherapy for prostate or bladder cancer Patients having taken opioids for more than seven days before surgery (to prevent peripheral withdrawal effects) Patients treated with drugs metabolized by certain enzymes (CYP3A4 and P-gp) Patients with severe hepatic impairment Patients with end-stage renal disease Patients with heart failure Patients with severe dementia that impacts daily functioning Pregnant and lactating females Not postmenopausal females and of childbearing potential and not using an accepted method of birth control (i.e, surgical sterilization; intrauterine contraceptive device; oral contraceptive, diaphragm) Patients participated in another investigational drug or medical device study within 30 days of surgery or planning to be enrolled in another investigational drug or medical device study or any study in which active patient participation was required outside normal hospital data collection during the course of this study Patients deprived of liberty or placed under the authority of a tutor or curator
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Dominique GENRE, MD
    Phone
    33 4 91 22 37 78
    Email
    drci.up@ipc.unicancer.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carine Cormary-Feuillet, PhD
    Phone
    33 4 91 22 58 82
    Email
    drci.up@ipc.unicancer.fr
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Géraldine Pignot, MD, PhD
    Organizational Affiliation
    Isntitut Paoli-Calmettes
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Evaluation of Naloxegol in the Prevention of POI After Cystectomy

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