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

This study has been terminated.

(Funding unavailable)

Sponsor:

Information provided by (Responsible Party):

Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT00536523

First received: September 27, 2007

Last updated: November 6, 2012

Last verified: November 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

September 27, 2007

Last Updated Date

November 6, 2012

Start Date ^ICMJE

April 2007

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Alterations in serotonin levels associated with increased constipation [ Time Frame: PreDose, Post 3rd Cycle, Post Treatment and 4 Months Post Treatment ] [ Designated as safety issue: No ]

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.

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT00536523 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

A blood sample (5 ml red top tube) will be drawn before the patient's first chemotherapy treatment, after the 3rd cycle of chemotherapy, at the post chemotherapy follow-up visit (approximately 30 days after chemotherapy is completed) and approximately 4 months after completion of chemotherapy at the time of a routine follow-up visit. Whenever possible, the blood will be drawn at the same time blood is being collected for clinical purposes therefore flexibility is allowed in the timing of the research related bloods.

Sampling Method

Probability Sample

Study Population

Women with newly diagnosed ovarian, fallopian tube, or primary peritoneal cancer.

Condition ^ICMJE

Constipation
Bowel Obstruction
Fallopian Tube Cancer
Ovarian Cancer
Peritoneal Cavity Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Patients Receiving Chemotherapy

Patients with newly diagnosed ovarian, fallopian tube or primary peritoneal cancer for which 6 cycles of a taxane and platinum containing regimen is planned

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

Completion Date

December 2009

Primary Completion Date

December 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00536523

Other Study ID Numbers ^ICMJE

2007NT031, WCC-52

Has Data Monitoring Committee

Yes

Responsible Party

Masonic Cancer Center, University of Minnesota

Study Sponsor ^ICMJE

Masonic Cancer Center, University of Minnesota

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:

Melissa A. Geller, MD

Masonic Cancer Center, University of Minnesota

Information Provided By

Masonic Cancer Center, University of Minnesota

Verification Date

November 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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