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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00536523

Enrollment

Registered

2007-09-28

Start date

2007-04-30

Completion date

2009-12-31

Last updated

2014-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

constipation, impaction, and bowel obstruction, ovarian epithelial cancer, peritoneal cavity cancer, fallopian tube cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Alterations in serotonin levels associated with increased constipation	PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment	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.

Countries

United States

Outcome results