Evaluation of Naloxegol in the Prevention of POI After Cystectomy

NCT04219046 | Unknown Phase 2

• 1 other identifier: ANTAGOCYST-01-IPC 2019-034
• Study Type: interventional
• Target: 102
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bladder Cancer; Cystostomy; Complications

Keywords

Radical cystectomy; Postoperative ileus; Enhanced Recovery After Surgery

Outcome Measures

Primary Outcomes (1)

• 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

  Date at which treatment is initiated and date of hospital discharge (up to 12 days)

Secondary Outcomes (4)

• Rate of reinsertion of nasogastric tube

  From post-surgery to hospital discharge (up to 12 days)

• Time to reach gastrointestinal recovery

  Date at which the patient has the first gaz from post-surgery (up to 12 days)

• Rate of 30-day postoperative complications

  Postoperative complications from surgery, to 30-day postsurgery and to 90 postsurgery with Clavien-Dindo classification (up to 3 motnhs)

• Rate of major postoperative complications of 90-day postoperative period

  Major postoperative complications from surgery to 90 postsurgery with Clavien-Dindo classification (up to 3 motnhs)

Study Arms (2)

Experimental Treatment

EXPERIMENTAL

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

Drug: Naloxégol oxalate

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo oral tablet

Interventions

Naloxégol oxalate DRUG

Oral administration once daily

Also known as: Naloxegol

Experimental Treatment

Placebo oral tablet DRUG

Oral administration once daily

Also known as: Placebo

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Institut Paoli-Calmettes: lead

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

naloxegol

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Géraldine Pignot, MD, PhD

  Isntitut Paoli-Calmettes

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominique GENRE, MD

CONTACT

33 4 91 22 37 78; drci.up@ipc.unicancer.fr

Carine Cormary-Feuillet, PhD

CONTACT

33 4 91 22 58 82; drci.up@ipc.unicancer.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, Double-blind, placebo-controlled

Study Record Dates

• First Submitted: December 20, 2019
• First Posted: January 6, 2020
• Study Start: March 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: December 1, 2022
• Last Updated: July 28, 2020

Record last verified: 2020-01