Ovarian Cancer Clinical Trial
Official title:
Women's Cancer Center Protocol #52: Alterations in Serum Serotonin Levels as a Mechanism for Chemotherapy Induced Constipation
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.
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Masonic Cancer Center at University of Minnesota | Minneapolis | Minnesota |
Lead Sponsor | Collaborator |
---|---|
University of Minnesota - Clinical and Translational Science Institute |
United States,
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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