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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Constipation, Bowel Obstruction, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients Receiving Chemotherapy<br>Patients with newly diagnosed ovarian, fallopian tube or primary peritoneal cancer for which 6 cycles of a taxane and platinum containing regimen is planned | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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constipation, impaction, and bowel obstruction, ovarian epithelial cancer, peritoneal cavity cancer, fallopian tube cancer