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

Ovarian Cancer Clinical Trial

Official title:

Women's Cancer Center Protocol #52: Alterations in Serum Serotonin Levels as a Mechanism for Chemotherapy Induced Constipation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00536523
• Other study ID #: 2007NT031
• Secondary ID: WCC-52
• Status: Terminated
• Phase: N/A
• First received: September 27, 2007
• Last updated: August 21, 2014
• Start date: April 2007
• Est. completion date: December 2009

Study information

• Verified date: August 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Bowel Obstruction
• Constipation
• Fallopian Tube Cancer
• Fallopian Tube Neoplasms
• Intestinal Obstruction
• Ovarian Cancer
• Peritoneal Cavity Cancer
• Peritoneal Neoplasms

Locations

Country	Name	City	State
United States	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Alterations in serotonin levels associated with increased constipation	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.	PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment	No