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
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Women's Cancer Center Protocol #52: Alterations in Serum Serotonin Levels as a Mechanism for Chemotherapy Induced Constipation

Resource links provided by NLM:


Further study details as provided by Masonic Cancer Center, University of Minnesota:

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA

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.


Enrollment: 13
Study Start Date: April 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536523

Locations
United States, Minnesota
Masonic Cancer Center at University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Masonic Cancer Center, University of Minnesota
Investigators
Study Chair: Melissa A. Geller, MD Masonic Cancer Center, University of Minnesota
  More Information

No publications provided

Responsible Party: Masonic Cancer Center, University of Minnesota
ClinicalTrials.gov Identifier: NCT00536523     History of Changes
Other Study ID Numbers: 2007NT031, WCC-52
Study First Received: September 27, 2007
Last Updated: November 6, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Masonic Cancer Center, University of Minnesota:
constipation, impaction, and bowel obstruction
ovarian epithelial cancer
peritoneal cavity cancer
fallopian tube cancer

Additional relevant MeSH terms:
Constipation
Intestinal Obstruction
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Peritoneal Diseases
Fallopian Tube Diseases
Serotonin
Serotonin Receptor Agonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 20, 2014