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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


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
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