Know Cancer

or
forgot password

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


Phase 3
18 Years
N/A
Open (Enrolling)
Female
Ovarian Cancer, Fallopian Tube Cancer, Primary Peritoneal Cancer

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Postoperative length of hospital stay

Outcome Time Frame:

Patients will be followed for the duration of their hospital stay, an expected average of 5 days

Safety Issue:

No

Principal Investigator

Jamie Bakkum-Gamez, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Mayo Clinic

Authority:

United States: Food and Drug Administration

Study ID:

12-004082

NCT ID:

NCT01704651

Start Date:

January 2013

Completion Date:

January 2015

Related Keywords:

  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Primary Peritoneal Cancer
  • Ovary
  • Ovarian
  • Fallopian
  • Peritoneal
  • Cancer
  • Gynecological
  • Female
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Mayo ClinicRochester, Minnesota  55905