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Accelerating Gastrointestinal Recovery

Information source: Mayo Clinic
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ovarian Cancer; Fallopian Tube Cancer; Primary Peritoneal Cancer

Intervention: Alvimopan (Drug); Placebo (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Jamie N. Bakkum-Gamez

Official(s) and/or principal investigator(s):
Jamie Bakkum-Gamez, MD, Principal Investigator, Affiliation: Mayo Clinic

Overall contact:
Maureen A Lemens, BSN, RN, Phone: 507-293-1487, Email: lemens.maureen@mayo.edu

Summary

This study is designed to determine whether an oral perioperative medication (alvimopan--a selective mu antagonist) improves bowel recovery over placebo after surgery for ovarian cancer.

Clinical Details

Official title: Accelerating Gastrointestinal Recovery in Women Undergoing Staging and/or Debulking Surgery for Epithelial Ovarian, Fallopian Tube, and Primary Peritoneal Carcinoma: A Randomized, Double-Blind, Placebo-Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention

Primary outcome: Postoperative length of hospital stay

Secondary outcome: Postoperative ileus incidence

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion criteria:

- Females at least 18 years of age

- Have an American Society of Anesthesiologists (ASA) Score of I to III

- Are consented for primary, interval, or secondary cytoreduction for ovarian, tubal,

or peritoneal cancer

- Are scheduled to have their nasogastric tube removed before the first postoperative

dose of study medication

- Are able to understand the study procedures, have agreed to participate in the study

program, and have voluntarily provided informed consent Exclusion criteria:

- Females younger than 18 years of age

- Known non-gynecologic malignancy presenting with similar signs/symptoms as ovarian,

tubal, or peritoneal cancer.

- Have taken more than 7 consecutive days of therapeutic doses of opioids immediately

prior to surgery

- Use illicit drugs or abuse alcohol

- Have had a prior total colectomy, gastrectomy, gastric bypass, or have a functional

colostomy or ileostomy

- Have an ongoing history of short bowel syndrome, chronic constipation (≤3 spontaneous

bowel movements per week) or chronic diarrhea

- Have received radiation therapy to the abdomen or pelvis within 3 months of scheduled

surgery

- Have chemotherapy or radiation induced bowel dysfunction

- Are pregnant (identified by a positive urine or serum pregnancy test) or lactating,

or are not postmenopausal (no menses for at least 1 year) and are of childbearing potential and not using an accepted method of birth control (ie, surgical sterilization, intrauterine contraceptive device, oral contraceptive, diaphragm, or condom in combination with contraceptive cream, jelly, or foam, or abstinence)

- Have participated in another investigational drug or medical device study within 30

days of surgery or will be enrolled in another investigational drug or medical device study or any study in which active patient participation is required outside normal hospital data collection during the course of this study

- Have clinically significant laboratory abnormalities at screening that would result

in the cancellation of surgery

- Have a diagnosis of severe hepatic insufficiency or end stage renal disease.

- Have a history of previous surgeries, illness, or behavior that in the opinion of the

investigator might confound the study results or pose additional risk in administering the study procedures

- Are unable to understand the study procedures and are not able to voluntarily

provided informed consent

Locations and Contacts

Maureen A Lemens, BSN, RN, Phone: 507-293-1487, Email: lemens.maureen@mayo.edu

Mayo Clinic, Rochester, Minnesota 55905, United States; Recruiting
Maureen A Lemens, BSN, RN, Phone: 507-293-1487, Email: lemens.maureen@mayo.edu
Additional Information

Starting date: January 2013
Last updated: June 3, 2015

Page last updated: August 20, 2015

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