Brief Title
Effect of Serotonin Level on Constipation Caused by Chemotherapy in Patients With Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Official Title
Women's Cancer Center Protocol #52: Alterations in Serum Serotonin Levels as a Mechanism for Chemotherapy Induced Constipation
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 Type
Observational
Primary Outcome
Alterations in serotonin levels associated with increased constipation
Condition
Constipation
Study Arms / Comparison Groups
Patients Receiving Chemotherapy
Description: Patients with newly diagnosed ovarian, fallopian tube or primary peritoneal cancer for which 6 cycles of a taxane and platinum containing regimen is planned
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
13
Start Date
April 2007
Completion Date
December 2009
Primary Completion Date
December 2009
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Melissa A. Geller, MD, ,
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT00536523
Organization ID
2007NT031
Secondary IDs
WCC-52
Responsible Party
Sponsor
Study Sponsor
University of Minnesota
Study Sponsor
Melissa A. Geller, MD, Study Chair, Masonic Cancer Center, University of Minnesota
Verification Date
August 2014