Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (ILEUS)
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|ClinicalTrials.gov Identifier: NCT03352414|
Recruitment Status : Recruiting
First Posted : November 24, 2017
Last Update Posted : May 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Ileus||Drug: Alvimopan Drug: Placebo||Phase 2|
Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a surgical procedure to treat cancer that has spread to the lining of the abdominal cavity (peritoneal metastases). It is associated with a prolonged time for return of bowel function after surgery.
Alvimopan is a drug used to speed up the time for return of bowel function after surgery. It works by blocking the opioid receptors in the gastrointestinal tract, which normally slow down bowel function in patients receiving postoperative opioid pain medication. It has not previously been tested in patients undergoing CRS/HIPEC.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||128 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||The ILEUS Study: A Phase 2 Randomized Controlled Trial Investigating Alvimopan for Enhanced Gastrointestinal Recovery After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy|
|Actual Study Start Date :||March 8, 2018|
|Estimated Primary Completion Date :||March 2020|
|Estimated Study Completion Date :||March 2021|
Other Name: Entereg
|Placebo Comparator: Placebo||
- Time to return of upper and lower GI function [ Time Frame: from surgery to discharge (generally no longer than two weeks) ]The later of the time from surgery that the participant first tolerates solid food and the time that the participant first passes a bowel movement.
- Prolonged ileus [ Time Frame: from surgery to discharge (generally no longer than two weeks) ]The proportion of patients who do not pass flatus or bowel movement greater than 7 days from the time of surgery.
- Time to return of bowel function components [ Time Frame: from surgery to discharge (generally no longer than two weeks) ]
The time from surgery until:
- The time to first flatus
- The time to first bowel movement
- The time to tolerance of solid food
- Time to discharge [ Time Frame: from surgery to discharge (generally no longer than two weeks) ]The time from surgery until discharge order written.
- Adverse events [ Time Frame: up to 30 days from surgery ]The number and proportion of adverse events.
- Subgroup analyses [ Time Frame: up to 30 days from surgery ]
All primary and secondary outcomes will be measured in the following subgroups:
- 0 vs. 1 or greater bowel anastomoses
- 0 vs. 1 or greater visceral resections
- high vs. low amount of postoperative opioid use
- epidural vs. no epidural
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352414
|Contact: Joel M Baumgartner, MD, MAS||(858) email@example.com|
|United States, California|
|UCSD Moores Cancer Center||Recruiting|
|La Jolla, California, United States, 92093-0987|
|Contact: Joel M Baumgartner, MD, MAS 858-246-0581 firstname.lastname@example.org|
|Principal Investigator:||Joel M Baumgartner, MD, MAS||UCSD|