Effect of Serotonin Level on Constipation Caused by Chemotherapy in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Terminated

• Conditions: Fallopian Tube Cancer; Constipation; Peritoneal Cavity Cancer; Bowel Obstruction; Ovarian Cancer

• Registration Number: NCT00536523
• Lead Sponsor: University of Minnesota

Brief Summary

RATIONALE: Gathering information about changes in serotonin levels in patients undergoing chemotherapy for ovarian cancer, fallopian tube cancer, or primary peritoneal cancer may help doctors learn more about constipation caused by chemotherapy.

PURPOSE: This clinical trial is studying how blood levels of serotonin effect constipation caused by chemotherapy in patients with newly diagnosed ovarian cancer, fallopian tube cancer, or primary peritoneal cancer.

Detailed Description

OBJECTIVES:

* To determine if there are any alterations in serotonin levels in patients undergoing chemotherapy for ovarian, fallopian tube, or primary peritoneal cancer and if this is associated with increased constipation.

OUTLINE: Patients undergo blood sample collection prior to beginning of planned postoperative chemotherapy, after 3 and 6 courses of chemotherapy, and at the 3-month surveillance visit. Patients also complete a bowel function questionnaire at these time points.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-09-27
• Study First Submitted QC: 2007-09-27
• Study First Posted: 2007-09-28
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-21
• Last Update Posted: 2014-08-22

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 13

Inclusion Criteria

• Newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer
• Planned to undergo 6 courses of a taxane and platinum-containing regimen

Exclusion Criteria

• Ovarian low malignant potential tumor
• History of constipation or irritable bowel syndrome
• History of colorectal cancer
• Prior bowel resection at time of staging/cytoreductive surgery
• Prior abdominal-pelvic radiation
• Prior bowel surgery

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Alterations in serotonin levels associated with increased constipation	PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment	Once the blood is drawn at the time of another necessary blood draw, the specimen will be labeled as a send out lab in the acute care lab. These are frozen and batched. Batched samples will then be sent to an outside laboratory for serotonin measurements.

Trial Locations

Locations (1)

Masonic Cancer Center at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States