Clinical trial NCT01704651: Accelerating Gastrointestinal Recovery
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Cancer
Keywords: Ovary
Ovarian
Fallopian
Peritoneal
Cancer
Gynecological
Female
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
First posted: 2012-10-11
Enrollment: 146
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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

Primary outcomes:
measure: Postoperative Length of Hospital Stay
timeFrame: Patients will be followed for the duration of their hospital stay, an expected average of 5 days
Secondary outcomes:
measure: Postoperative Ileus Incidence
timeFrame: Patients will be followed for 30 days postop
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Jamie Bakkum-Gamez, MD
role: PRINCIPAL_INVESTIGATOR
References: