Accelerating Gastrointestinal Recovery

Jamie N. Bakkum-Gamez

Status and phase: Completed; Phase 3

Conditions: Peritoneal Cancer; Fallopian Tube Cancer; Ovarian Cancer

Treatments: Drug: Alvimopan; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01704651

12-004082

Details and patient eligibility

About

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.

Enrollment: 146 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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146 participants in 2 patient groups, including a placebo group

Alvimopan

Experimental group

Description:

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.

Treatment:

Drug: Alvimopan

Placebo

Placebo Comparator group

Description:

Perioperative administration of placebo, at same dosing interval as study drug.

Treatment:

Drug: Placebo