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


N/A
18 Years
N/A
Not Enrolling
Female
Constipation, Bowel Obstruction, Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Cavity Cancer

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Alterations in serotonin levels associated with increased constipation

Outcome Description:

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.

Outcome Time Frame:

PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment

Safety Issue:

No

Principal Investigator

Melissa A. Geller, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota

Authority:

United States: Institutional Review Board

Study ID:

2007NT031

NCT ID:

NCT00536523

Start Date:

April 2007

Completion Date:

December 2009

Related Keywords:

  • Constipation
  • Bowel Obstruction
  • Fallopian Tube Cancer
  • Ovarian Cancer
  • Peritoneal Cavity Cancer
  • constipation, impaction, and bowel obstruction
  • ovarian epithelial cancer
  • peritoneal cavity cancer
  • fallopian tube cancer
  • Constipation
  • Intestinal Obstruction
  • Ovarian Neoplasms
  • Peritoneal Neoplasms
  • Fallopian Tube Neoplasms

Name

Location

Masonic Cancer Center at University of MinnesotaMinneapolis, Minnesota  55455