Accelerating Gastrointestinal Recovery

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Ovarian Cancer; Fallopian Tube Cancer; Peritoneal Cancer	Drug: Alvimopan; Drug: Placebo	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	146 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Triple (Participant, Care Provider, Investigator)
Primary Purpose:	Prevention
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 Start Date :	January 2013
Actual Primary Completion Date :	August 2015
Actual Study Completion Date :	October 2015

Arms and Interventions

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Arm	Intervention/treatment
Experimental: Alvimopan; Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative. Drug was continued for duration of hospital stay, but did not exceed 7 days.	Drug: Alvimopan; Perioperative administration of oral alvimopan, 12mg twice daily, starting with 1 dose preoperative.; Other Name: Entereg
Placebo Comparator: Placebo; Perioperative administration of placebo, at same dosing interval as study drug.	Drug: Placebo; Perioperative administration of placebo, at same dosing interval as study drug.

Outcome Measures

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Primary Outcome Measures :

1. Postoperative Length of Hospital Stay [ Time Frame: Patients will be followed for the duration of their hospital stay, an expected average of 5 days ]
   Length of stay = date/time of hospital dismissal - date/time of end of surgery

Secondary Outcome Measures :

1. Postoperative Ileus Incidence [ Time Frame: Patients will be followed for 30 days postop ]
   Ileus was defined as MD-diagnosed, return to nothing by mouth (NPO) status, or insertion of nasogastric tube for ileus.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Jamie N. Bakkum-Gamez

Cubist Pharmaceuticals LLC

Investigators

Principal Investigator:	Jamie Bakkum-Gamez, MD	Mayo Clinic

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Jamie N. Bakkum-Gamez, Consultant and Assistant Professor of Obstetrics-Gynecology,, Mayo Clinic
ClinicalTrials.gov Identifier:	NCT01704651 History of Changes
Other Study ID Numbers:	12-004082
First Posted:	October 11, 2012
Results First Posted:	October 24, 2016
Last Update Posted:	October 24, 2016
Last Verified:	August 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Undecided

Keywords provided by Jamie N. Bakkum-Gamez, Mayo Clinic:

Ovary; Ovarian; Fallopian; Peritoneal	Cancer; Gynecological; Female

Additional relevant MeSH terms:

Fallopian Tube Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms	Fallopian Tube Diseases; Adnexal Diseases; Genital Diseases, Female; Alvimopan; Gastrointestinal Agents